Experience Database Research Articles

CRT-600.07 Safety Events With Large-Bore Mechanical Thrombectomy Devices: An Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience Database From 2018 to 2021

CRT-600.07 Safety Events With Large-Bore Mechanical Thrombectomy Devices: An Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience Database From 2018 to 2021

Leadless pacemaker perforations: Clinical consequences and related device and user problems.

BackgroundCardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA).MethodsFDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems.ResultsBetween 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and 146 patients (26%) required emergency surgery. Half of perforations were associated with 139 (25%) device problems, 78 (14%) operator use problems, and 62 (11%) combined device and operator use problems. Inadequate electrical measurements or difficult positioning were the most frequent device problems (n = 129); non‐septal implants and perforation of other structures were the most frequent operator use problems (n = 69); a combined operator use and device problem resulted in 62 delivery system perforations. No device or operator use problem was identified for 282 perforations (50%), but they were associated with 78 deaths, 245 tamponades, and 57 emergency surgeries.ConclusionThe Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.

Adverse events associated with AXIOS stents: Insights from the manufacturer and user facility device experience database.

ABSTRACTBackground and Objectives:The AXIOS stent is indicated for transgastric or transduodenal drainage of symptomatic pancreatic pseudocysts and symptomatic walled off necrosis. The AXIOS stent functions as a conduit which allows solid and liquid pancreatic fluid collections (PFC) contents to pass into the luminal GI tract and also allows the passage of standard and therapeutic endoscopes into the PFC to perform endoscopic debridement. We aim to investigate the number and type of complications associated with AXIOS stents.Materials and Methods:We analyzed postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database January 2016 to February 2021.Results:During the study period, approximately 588 reports with 579 device issues and 250 patient complications were identified. Most device complications were due to stent positioning problems or stent malpositioning (n = 206; 35.6%), followed by stent migration (n = 72; 12.4%), premature deployment (n = 61; 10.5%), material integrity (n = 56; 9.6%), deployment failure (n = 47; 8.1%), and difficulty removing the stent (n = 45; 7.7%). The most reported patient adverse events were hemorrhage/bleeding (n = 81; 32.4%), perforation (n = 26; 10.4%), pain (n = 22; 8.8%), unspecified infection (n = 20; 8.0%), and death (n = 17; 6.8%).Conclusions:Findings from the MAUDE database highlight patient and device complications which endoscopists should be aware of before AXIOS stent placement.

Stapler Malfunctions in Bariatric Surgery: An Analysis of the MAUDE Database.

Background:Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported to the Food and Drug Administration which maintains the Manufacturer and User Facility Device Experience (MAUDE) database. We examined adverse stapler events reported to the MAUDE database, specifically with regards to bariatric surgery.Methods:The MAUDE database was queried for adverse events caused by staplers between January 1, 2018 – December 31, 2020; events reported by Intuitive, Ethicon, and Medtronic/Covidien; and limited our search to “gastric bypass”, “sleeve gastrectomy”, “stapler malfunction” combined with each company.Results:There were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive. Approximately 3.5 million staple reloads sold in the study period. The reported misfire rate for Medtronic was 0.04% and for Ethicon was 0.02%. Data for Intuitive was unavailable. The most common reported event for Medtronic was failure to fire (n = 349), followed by misfire (n = 186). For Ethicon, the most common event was failure to fire (n = 146), followed by mechanical problems (n = 27). The most common event with the Intuitive stapler was leak (n = 10) and bleeding from staple line (n = 8).Conclusions:Stapler malfunction is a very rare event in metabolic and bariatric surgery. All of the major stapler producers have transitioned to powered staplers with excellent safety profiles. Open and honest reporting about stapler malfunction is essential to determine the true safety of these ubiquitous devices.

Clinical adverse events and device failures for the Barrx™ radiofrequency ablation catheter system: a MAUDE database analysis.

BackgroundThe Barrx™ radiofrequency ablation (RFA) catheter system comes in several different variations and sizes and is widely used for the eradication of Barrett’s esophagus (BE). The Barrx™ 360 and 360 Express system is used to perform circumferential RFA, while the Barrx™ focal catheter system is used for secondary focal RFA or primary treatment of short-segment BE. We aimed to investigate the number and type of complications and device failures associated with the Barrx™ RFA catheter system.MethodWe analyzed post-marketing surveillance data from the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database from August 2011 to August 2021.ResultsDuring the study period, 148 unique reports detailing 78 device issues and 87 patient-related adverse events were identified. The most reported adverse events for patients were stenosis secondary to treatment (n=15, 17.24%), mucosal laceration of the esophagus (n=13, 14.94%), chest pain (n=10, 11.49%), and odynophagia/dysphagia (n=7, 8.05%). The most common device complication was failure of the device to deploy when activated (n=10, 13.82%). Other device malfunctions included material deformation/distortion (n=7, 8.97%), catheter breakage (n=6, 7.69%), connection problems between the generator cable and RFA device (n=6, 7.69%), and failure of the balloon to properly inflate (n=5, 6.41%).ConclusionFindings from the MAUDE database highlight patient and device complications that endoscopists should be aware of prior to RFA of BE with the Barrx™ RFA catheter system.

Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery.

Background and Objectives:This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic surgery.Methods:Utilization rates for oxidized regenerated cellulose powder (ORC), polysaccharide powder (PSP), and fibrin sealant solution (FSS) were obtained from hospitals via the Premier Healthcare databases for all surgical procedures from January 1, 2018 to September 30, 2020. All reported cases were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for ORC and PSP and from the FDA Adverse Event Reporting System (FAERS) database for FSS. Distributions of AEs by anatomical site (MAUDE/FAERS) and surgical procedures by specialty (Premier) were evaluated for each product. Number of cases and number and types of AEs were compared to the total utilization for each product.Results:PSP was the most used product during the period analyzed (n = 126,509 uses), followed by FSS (n = 80,628 uses), and ORC (n = 41,583 uses). Distribution of surgical procedures by anatomical site varied significantly between hemostatic agents (p < 0.001). ORC was associated with more patient cases with AEs and numbers of reported AEs compared with PSP and FSS (p < 0.001). ORC was associated with higher number of infections than PSP (p < 0.001) and FSS (p < 0.001).Conclusion:These findings suggest that ORC use in abdominal and pelvic surgery may result in more postoperative complications compared with non-ORC hemostatic agents. Further prospective randomized studies are needed to compare efficacy and safety of these products.

Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.

To develop an annotation model to apply natural language processing (NLP) to device adverse event reports and implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. We included adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 related to device removal following hysteroscopic sterilization. We used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. We assessed the model performance using positive predictive value (PPV, also known as precision), sensitivity (also known as recall), and F1 score (a combined measure of PPV and sensitivity). Using extracted variables, we summarized the reporting source, the presence of prespecified and other patient and device events, additional sterilizations and other procedures performed, and time from implantation to removal. The overall F1 score was 91.5% for labeled items and 93.9% for distinct events after excluding duplicates. A total of 16 535 reports of device removal were analyzed. The most frequently reported patient and device events were abdominal/pelvic/genital pain (N=13 166, 79.6%) and device dislocation/migration (N=3180, 19.2%), respectively. Of those reporting an additional sterilization procedure, the majority had a hysterectomy or salpingectomy (N=7932). One-fifth of the cases that had device removal timing specified reported a removal after 7 years following implantation (N=2444/11 293). We present a roadmap to develop an annotation model for NLP to analyze device adverse event reports. The extracted information is informative and complements findings from previous research using administrative data.

Postmarket Safety Surveillance of Delayed Complications for Recent FDA-Approved Hyaluronic Acid Dermal Fillers.

To review postmarketing data for delayed (≥14 days post-treatment) adverse events (AEs) of interest (inflammatory and noninflammatory nodules, hypersensitivity, granulomas) for newer hyaluronic acid (HA) fillers FDA-approved within the last 5 years (2016-2020). Reports from the Manufacturer and User Facility Device Experience (MAUDE) database were extracted for HAREF, HADEF, HAKYS, HAVER, HAVLR, HAVOB, HARH2, HARH3, and HARH4 from January 2016 to January 2021. Keywords from event narratives were used to identify and categorize AEs and then verified through inclusion/exclusion criteria. Percentages are based on the total combined events of interest to provide an overall perspective of the events reported during the search period. Of 585 MAUDE reports, there were 195 (33.3%) delayed AEs of interest. Of those, 71.8% were nodules (42.1% inflammatory and 29.7% noninflammatory), 21.5% hypersensitivity, and 6.7% granulomas. The combined total events of interest, ordered by frequency reported, were HAVLR (74.4%), HAVOB (12.3%), HADEF (5.1%), HARH4 (3.6%), HAREF (2.6%), and HARH2 (2.1%), with no reports for HARH3, HAVER, and HAKYS. Although delayed nodules and inflammatory events are rare, reports for these events were extracted from the MAUDE database from 2016 to 2020 for HAVLR, HAVOB, HADEF, HARH4, HAREF, and HARH2 (most to least frequent).

Food and Drug Administration Approved Innovative Duodenoscope Designs: Reports From the Manufacturer and User Facility Device Experience Database

Duodenoscopes are used for more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures annually in the United States. 1 U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes. Accessed July 11, 2021. Google Scholar Although most endoscopes are susceptible to risk of infectious transmission, duodenoscopes are uniquely susceptible due to procedural considerations (frequent intervention in an infected milieu such as cholangitis and frequent removal of foreign bodies such as stents through the working channel) and scope considerations (elevator mechanism making reprocessing more complex and difficult). 2 Kovaleva J et al. Clin Microbiol Rev. 2013; 26: 231-254 Google Scholar ,3 Rubin ZA Murthy RK. Curr Opin Infect Dis. 2016; 29: 407-414 Google Scholar Since 2012, more than 25 duodenoscope-related outbreaks of multidrug-resistant organisms have occurred worldwide, infecting at least 250 people. 4 U.S. Senate. Senate Health. Education, Labor and Pensions Committee & Minority Staff Report. https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation %20FINAL%20Report.pdf. Accessed July 12, 2021. Google Scholar

Complications associated with Dermabond® during head and neck surgery: MAUDE and literature review

IntroductionDermabond® is a liquid surgical sealant containing 2-octyl-cyanoacrylate that has been widely used during head and neck surgeries. This study aims to provide a summary of adverse events related to Dermabond® in head and neck procedures as reported in the MAUDE database, and to report a complete overview of all documented adverse events related to Dermabond® use in current literature. MethodsThe US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of adverse events related to Dermabond® use from January 1, 2010, to February 1, 2020. Data were extracted from reports pertaining to head and neck procedures. In addition, literature review was performed from January 1970 to January 2021. Various adverse events related to Dermabond® were included in the study. ResultsWe identified 32 adverse events, from which 29 (90.6%) were patient-related events and 3 (9.4%) were operator-related events. Of the patient-related events, contact dermatitis (CD) (20 [69.0%]) was the most common, followed by wound dehiscence (4 [13.8%]). All of the operator-related events were from inadvertent cut injury (3 [100%]). Following the literature review, adverse events of Dermabond® were categorized into CD, wound dehiscence, infection, and cut injury. ConclusionDermabond® demonstrated utility in various surgical procedures including head and neck surgeries but are associated with risks. This study identified adverse events associated with Dermabond®. Further studies are needed to establish the causation of contact dermatitis in certain populations.

Analysis of Reported Adverse Events With Colonic Stents: An FDA MAUDE Database Study.

Colonic stents are indicated for preoperative and palliative decompression of large bowel obstruction. We aim to investigate post Food and Drug Administration (FDA) approval outcomes associated with colonic stents. We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to December 2020. During the study period, 691 device issues and 742 patient complications were identified. The number of adverse events reported to the FDA mildly increased from 6.40% in 2011 to 7.4% in 2020. Most device complications were due to a positioning problem (n=201, 29%), followed by device break (n=60, 8.6%), delamination (n=41, 6.3%), and migration or expulsion device (n=38, 5.55%). A number of reports described an unclassified adverse event without specifying device or operator problem (n=141, 20.3%). The most reported patient adverse events were perforation (n=150, 20.1%), death (n=47, 6.3%), abdominal pain/discomfort (n=27, 3.6%), and peritonitis (n=24, 3.2%). Findings from the MAUDE database highlight rare but important patient and device complications which endoscopists and referring providers should be aware of before consideration for colonic stent placement.

A review of hospital based ventilator malfunctions reported to the FDA in 2021

Ventilator care is synonymous with Intensive care. These devices are electromechanical and as such can fail. Most failures are without patient incident, injury, and harm. The FDA requires manufacturers who learn of malfunction, injury or death while operating their product to report to the agency via the Manufacturer and User Facility Device Experience database. I reviewed 500 recent events reported to the FDA and found an increasing trend from 2020 to 2021 in hospital ventilator malfunction reports. Examination of these reports is critical to assuring quality ventilator care. The author concluded that intensive training on the device characteristics and feature and a more rigorous examination of ventilator performance between patients may assist in reducing device malfunctions. Keywords: Mechanical ventilation, Ventilator malfunction, FDA

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry.

Purpose: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015, and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups. Results: A total of 391 adverse events were reported: aquablation (n = 102), PUL (n = 132), and TWVT (n = 157). There were 79 (78%) severe or life-threatening adverse events for aquablation vs 69 (52%) for PUL vs 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were aquablation-32 (31%), PUL-21 (16%), and TWVT-1 (1%). The most common device malfunctions were: aquablation-motion error (n = 8), handpiece fracture/attachment malfunction (n = 8); PUL-device misfire (n = 27), needle fragmentation (n = 21); TWVT-unresolvable error message (n = 19). Conclusions: In a national database, aquablation and PUL had noteworthy complications or device-related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.

Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database.

Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. Retrospective analysis of the MAUDE database. The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database.

Adverse Events With Intravascular Lithotripsy After Peripheral and Off-Label Coronary Use: A Report From the FDA MAUDE Database.

Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.

Abstract 11755: Adverse Events of Third Generation Left Ventricular Assist Devices: Insights From the Manufacturer and User Facility Device Experience Database

Background: Left ventricular assist devices (LVAD) are used frequently to treat end-stage heart failure. The HeartMate 3 (HM-3), the newest LVAD, has limited data on complications. We analyzed the post-marketing surveillance data from the Manufacturer and User Facility Device Experience (MAUDE) database to evaluate complications from the HM-3. Methods: We queried the MAUDE database for device event reports of the HM-3 LVAD from 1/1/2017 to 12/31/2019. We screened event reports for completeness, stratified complications into the device and patient effects, and used descriptive analyses on the compiled reported complications. Results: In this time period, 3,867 device reports met the search criteria, of which 961 identifiable device-specific complications were reported. The most common device events reported were infusion flow disruptions (21.0%), halted pump (9.2%), and material deformation (8.4%). Additionally, 5,676 events affecting patients were also reported in this period. Not counting death, blood loss (21.8%), infection (17.8%), and thrombus (3.3%) were the most commonly reported clinical events. Lastly, 535 deaths were reported, stemming from cerebral vascular accidents (9.7%) and hemorrhage (6.7%). Device events, patient events, with device and patient events associated with death are represented in Figure 1 . Conclusion: Findings from the MAUDE database provide insight into complications and risks of the HM-3 LVAD. Addressing the complications and understanding the risk may improve clinical outcomes for patients with refractory heart failure. Figures 1A, 1B, 1C, 1D

Abstract 11217: Adverse Events Associated with AV Node Ablation in Patients with an Implanted Leadless Pacemaker

Introduction: The Micra leadless intracardiac pacemaker (LICP) is an FDA-approved right ventricular pacemaker that has been available worldwide since 2016. It is frequently implanted in patients who have atrial fibrillation and who undergo atrioventricular node ablation (AVN-AB) for rate control. The potential adverse effects of AVN-AB on LICP performance and function are unknown. Hypothesis: AVN-AB may increase LICP pacing thresholds and/or cause exit block or damage the LICP's electronics. Methods: The FDA Manufacturers and User Facility Device Experience (MAUDE) database was searched for Micra LICP adverse events associated with AVN-AB that were submitted by the manufacturer and received by the Food and Drug Administration from 2016-April 2021. Results: The search found 19 cases of pacing threshold elevation following AVN-AB that were performed during (n=9) or after (n=10) LICP implantation. Exit block resulted in asystole or marked bradycardia in 12 patients (63.2%); 2 of these patients required cardiopulmonary resuscitation. In 8 patients, a persistently high threshold or exit block required LICP replacement with either a new LICP or a transvenous pacemaker. Four explanted LICPs were returned and analyzed by the manufacturer and no pulse generator electronic abnormalities were found. Conclusions: AVN-AB during or after LICP implantation may result in persistently high pacing thresholds or exit block and necessitate LICP replacement; this appears to be a local effect at the LICP electrode-tissue interface rather than effects on LICP electronic function. Additional clinical safety data are needed, especially since patients may be rendered pacemaker-dependent after AVN-AB.

Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis.

Transoral incisionless fundoplication (TIF) has been used for treating chronic gastroesophageal reflux disease (GERD) refractory to medical therapy. We aim to investigate the complications associated with TIF using a national database. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021. During the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R2 = 0.96) but increased from 2016 to 2020 (R2 = 0.99). The most common adverse event was perforation (19.8%), followed by laceration 17.6%, bleeding (9.2%), and pleural effusion (9.2%). The most common patient complications were treated using endoscopic clips (12.3%), chest tube or drain insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent or open surgery (11.1%). Adverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.

Analysis of Complications in Sacroiliac Joint Fusions Using FDA 510(k) Cleared Devices.

This was a level III-retrospective cohort study. The objective of this study was to present an unbiased report of the current rate of severe complications for Federal Drug Administration (FDA) 510(k) cleared sacroiliac joint (SIJ) fusions and investigate the underlying cause of these complications. The number of yearly SIJ fusions is on an upward trend. Currently, the most utilized implants to fuse the SIJ have been FDA 510(k) cleared devices. Studies reporting on complications following SIJ fusions are mostly industry-sponsored. The Manufacturer and User Facility Device Experience (MAUDE) database was searched for all reported FDA 510(k) cleared SIJ fusion device complications. Several data points were obtained from each report and recorded. The Hospital Inpatient National Statistics and the Center for Medicare and Medicaid Services (CMS) was also searched for the number of SIJ fusions performed each year. A search of the MAUDE database returned 1115 reports, with the first report on June 30, 2011, and the last report on July 28, 2020. Patient injury was the most common type of event reported at 97.5% (1080/1107). Death was reported in 3 patients (0.3%). Malposition was the most common device problem at 49.5% (548/1107). The root cause of these events was primarily user error at 58.2% (644/1107). Revision surgery or reoperation occurred in 92.8% (1028/1107) of reports. Data for SIJ fusions through CMS showed an overall trend of increasing yearly SIJ fusions. The majority of complications reported to MAUDE for FDA 510(k) cleared SIJ fusion devices are user error due to improper placement of implants. These complications are likely underreported, and there is currently no formal tracking system of total SIJ fusions performed to calculate accurate complication and revision rates. Patient injury and health care costs can potentially be reduced with improved education, training, and oversight, which is currently lacking.

Quantification of device-related event reports associated with the CardioMEMS Heart Failure System

Abstract Introduction The CardioMEMS (Abbott) is an implantable pulmonary artery pressure monitor for heart failure patients approved by the United States Food and Drug Administration (FDA) based on the CHAMPION trial reporting a reduction in the composite outcome of heart failure hospitalizations (HFH) and all-cause mortality. The result was driven by reduction in HFH; there was no benefit on mortality. While CardioMEMS was approved by the FDA in May 2014 and received Conformitè Europënne (CE) Mark approval in December 2014, the FDA review found preferential attention towards patients in the treatment arm that may have biased results. The FDA-mandated industry-sponsored post-marketing study identified 5 device-related complications in a 1,200-patient cohort from September 2014 to October 2017. A separate review of adverse events reported to the FDA during a similar timeframe from May 2014 to May 2017 identified 155 instances of injury or death. As worldwide implantation rates of CardioMEMS have increased since 2017 to roughly 20,000, we updated device-related events reported to the FDA to aid in understanding its current real-world safety profile. Methods The FDA mandates reporting of all medical device-related events to the Manufacturer and User Facility Device Experience (MAUDE) database, a passive surveillance system. We queried all available reports from May 28, 2014 to November 28, 2020 using the unique product code for CardioMEMS (“MOM”). Almost all reports (96%) contained a narrative description, which was used to enumerate adverse events. Results A total of 2,861 MAUDE reports have been filed for CardioMEMS in the reporting period, increasing from an average of 38 reports per 6-month period from May 2014 to May 2017 to an average of 149 reports per 6-month period afterwards (Figure 1). The majority reported inaccurate measurements, which required replacement of the external unit, repeat non-invasive testing, or repeat catheterization to resolve (Table). There were 169 (5.9%) patient deaths reported; most commonly reported non-fatal safety events included hemoptysis, heart failure exacerbation, and significant bleeding at the groin site (Table 1). Conclusion We found an increased number of adverse events associated with CardioMEMS in the last 3 years compared to the first 3 years, partially coinciding with increased use. Safety of CardioMEMS should be considered along with the lack of evidence of benefit on all-cause mortality from clinical trials. MAUDE has the known limitation of incomplete adverse event reporting, thus actual adverse event rates are certainly higher. Another limitation is lack of an exact denominator as number of implantations annually is not publicly available. Our analysis demonstrates risks associated with CardioMEMS implantation that are increasing in number. These data can more accurately inform discussions regarding risks and benefits between patients, physicians, and policymakers when considering CardioMEMS. Funding Acknowledgement Type of funding sources: None. FigureTable