Manufacturer's Database Research Articles

Investigating the Complications and Causes of Failure of the AngioVac System: A Post-Marketing Surveillance From the MAUDE Database.

Background Aspiration thrombectomy devices, such as the AngioVac, allow the removal of thrombus, especially in patients with contraindications to anticoagulation use. The AngioVac was approved by the U.S. Food and Drug Administration to remove fresh, soft thrombi or emboli during extracorporeal bypass for up to six hours. Real-world data on the most common modes of failure and complications associated with the AngioVac are unavailable. Methods The Manufacturer and User Facility Device Experience database was queried for reports of the AngioVac device failure and adverse events from April 2013 to March 2022.Categorical variables were described as numbers, and all statistical calculations were performed with IBM SPSS Statistics, version 27.0 (IBM Corp., Armonk, NY). Results A total of 115 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 93 reports. The most common mode of failure for the AngioVac was physical damage of the device, with 13 reports (14%). The most common vessels associated with events were the superior vena cava and inferior vena cava, occurring in 23 reports (24.7%). The most common adverse clinical events were pulmonary embolism (PE), occurring in 33 reports (35.5%), and perforation, occurring in 16 reports (17.2%). Other less frequent adverse outcomes were arrhythmias, stroke, and foreign body device embedment. There were 45 deaths reported with the use of the AngioVac. Conclusions Aspiration thrombectomy devices provide promising efficacy; however, physicians should be aware of known adverse outcomes, even if they are infrequent. Based on this analysis, PE and vessel perforation were the most common adverse outcomes. Furthermore, the most common mode of failure was secondary to physical damage of the device.

The Prevalence of Cardiovascular Complications and Causes of AngioJet Failure: A Post-Marketing Surveillance Study Based on the MAUDE (Manufacturer and User Facility Device Experience) Database.

Background and objective Aspiration thrombectomy devices, such as the AngioJet Solent Omni (Boston Scientific Corporation,Marlborough, MA) have been approved by the US FDA for the treatment of thrombi in peripheral arterial disease, venous disease, and AV fistulas. However, there is a dearth of real-world data on the most common modes of failure and complications associated with the AngioJet Solent Omni. In this study, we aimed to address this scarcity of data. Methods The MAUDE (Manufacturer and User Facility Device Experience) database was queried for reports of device failure and adverse events spanning the period from October 2012 to December 2021. Results A total of 499 events were reported during the study period. After the exclusion of duplicate reports, the final analysis included 450 reports. The most common mode of failure was catheter breakage/kinking during suction thrombectomy with 137 reports (30%). The most common vessel associated with events was the superficial femoral artery or vein, which was documented in 82 reports (18.2%). The most common adverse clinical outcome was the embedding of a piece of the device in the patient, which occurred in seven reports (1.6%). There were seven (1.6%) events of death reported during the period studied. Conclusions Based on our findings, theAngioJet Solent Omni deviceprovides promising results; however, it is important to evaluate device safety. It is associated with complications including device embedment, catheter breakage/kinking, and death, and these adverse events are linked to patient characteristics and risk factors.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Adverse Events Related to Direct-To-Consumer Sequential Aligners-A Study of the MAUDE Database.

Background-Direct-to-consumer (DTC) sequential aligners promote "teeth straightening" at a low cost and with added patient convenience. DTC sequential aligners have risen in popularity among the general public and sparked debate among dental professionals. Dental professionals argue that using these aligners without an in-person diagnosis and treatment planning protocol set by a licensed dentist or orthodontist may lead to adverse effects on teeth and surrounding structures. The objective of this study is to describe adverse clinical events associated with the use of DTC sequential aligners as reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (FDA MAUDE) database. Methods-We searched the MAUDE database from 1 January 2010 to 31 December 2020 for the product code of 'NXC' (sequential aligners). The year, type of adverse event, reporter occupation, and event description were noted. Results-651 reports associated with sequential aligners were found, of which 104 were related to DTC sequential aligners. Fifty-four adverse events were reported in 2019. From the event description, 41.3% comprised bite problems, 29.8% comprised orofacial pain, and 26.6% of patients had some form of periodontal sequelae. Furthermore, 69.2% of the patients followed up after an adverse event with a dentist not associated with DTC aligners. Conclusions-The use of DTC sequential aligners without dental supervision has led to oral health problems, as documented in the MAUDE database. Commonly reported adverse events include bite problems, pain, sensitivity, and periodontal disease, and some adverse events are irreversible.

Airway fires in otolaryngologic surgery: A database review

PurposeAn estimated 34 % of reported operating room fires involve the airway. Despite the inherent risks in otolaryngologic surgery, education regarding prevention and management of airway fires is limited in graduate medical training. One contributing factor is a lack of reporting of such rare events in our literature. MethodsThe U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to fires occurring during surgical procedures of the airway from January 1, 2010, to March 31, 2020. Results3687 reports were identified and 49 unique reports of airway fire were included. Sustained fires were described in 16 (32.7 %) reports and 33 (67.3 %) described transient flares. 2 fires extended beyond the airway and 9 (18.4 %) were noted to have occurred at the start of the case. Fires were reported most commonly during tonsillectomy (n = 22 [44.9 %]), vocal fold excision (n = 5 [10.2 %]), and adenoidectomy (n = 4 [8.2 %]). 46 reports attributed flare initiation to a specific element of the fire triangle. 16 patient and 2 operator injuries were reported. Saline washing was utilized in 7 (14.3 %) cases overall. Patients were extubated immediately in 2 (12.5 %) of the 16 reports of sustained fires. 0 mortalities were reported. ConclusionAirway fires were reported in a variety of upper airway procedures performed regularly by otolaryngologists. The triggering factor that led to fire was identified as a spark or char in about half of the reported cases, and only 2 reports described immediate removal of the endotracheal tube.

Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation.

Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration (FDA) has approved the use of balloon dilation devices produced by three manufacturers, but little is known about associated adverse events and subsequent management. Case series. FDA Manufacturer and User Facility Device Experience(MAUDE) database. Reports submitted to the FDA using the MAUDE database searched from January 2000 to July 2022 were analyzed for adverse events and management. A total of 13 adverse events were found in the database. Subcutaneous emphysema (n = 8) was the most common event. Other less frequent events included patulous Eustachian tube (n = 2), vascular dissection (n = 1), nasopharyngeal mucocele (n = 1), and tinnitus (n = 1). A majority of patients who experienced subcutaneous emphysema received antibiotics (n = 5) and were admitted to the hospital (n = 4). The patient with a carotid dissection 7 days postprocedure presented with a stroke and fully recovered after stent placement. There was limited preprocedure information in the MAUDE database. There were 2 patients who did not fully recover after a complication. Three patients underwent corrective surgical interventions. No one company had more associated adverse events reported. Subcutaneous emphysema is the most common adverse event after Eustachian tube dilation. Further studies exploring potential balloon dilation adverse events to allow for better patient counseling are warranted.

Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User Facility Device Experience (MAUDE) Database.

The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal. The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022. A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire(66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001). Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians toanticipatecomplications and escalate careappropriately.

Surgical Fires Involving Alcohol-Based Preparation Solution, 1991-2020.

Alcohol-based skin preparations were first approved for surgical use in 1998 and have since become standard in most surgical fields. The purpose of this report is to examine incidence of surgical fires because of alcohol-based skin preparation and to understand how approval and regulation of alcohol-based skin preparations impacted trends in fires over time. We identified all reported surgical fires resulting in patient or staff harm from 1991 through 2020 reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. We examined incidence of fires because of these preparations, trends after approval and regulation, and common causes. We identified 674 reports of surgical fires resulting in harm to patients and surgical personnel, in which 84 involved an alcohol-based preparation. The time-adjusted model shows that from 1996 through 2006, there was a 26.4% increase in fires followed by a 9.7% decrease from 2007 to 2020. The decrease in fires was most rapid for head and neck and upper aerodigestive tract surgeries. Qualitative content analysis revealed improper surgical site preparation as well as close proximity of surgical sites to an oxygen source as the most common causes of fires. Since FDA approval, alcohol-based preparation solutions have been associated with a significant percentage of surgical fires. Warning label updates from 2006 to 2012 coupled with increased awareness efforts of associated risks of alcohol-based surgical solutions likely contributed to the decrease in fires. Improper surgical site preparation technique and close proximity of surgical sites to oxygen continue to be risk factors for fires. 4 Laryngoscope, 134:607-613, 2024.

Complications and device failures associated with urolift: Findings from the MAUDE database.

Urolift is an established intervention for symptoms of bladder outflow obstruction caused by benign prostate enlargement. Reported advantages include its minimally invasive profile, short learning curve and feasibility as a day case procedure. Our aim was to use a national registry as a means to evaluate the nature of complications and device failures that have been documented to occur. Retrospective review was performed of the US Manufacturer and User Facility Device Experience (MAUDE) database, a prospective register, which contains voluntarily submitted adverse events associated with surgical devices. Information collected include event timing, underlying cause, procedural completion, complications and mortality status. Between 2016 and 2023, 103 device failures, 5 intra-operative complications and 165 post-operative complications (early: 151, late: 14) were registered. The commonest device problem (56%, n = 58) was failure of the implant to deploy with subsequent requirement for complete replacement. There were 50 cases of documented urosepsis. 62 patients with post operative haematuria were registered including 12 that underwent emergency embolisation. Other complications included stroke (n = 5), pulmonary embolism (n = 3) and necrotising fasciitis (n = 1). Twelve ITU admissions were registered. In the reports, 22 cases were filed that recorded a hospital stay of 7 days or more. Eleven deaths were captured in the database over the study period. While urolift is recognised as less invasive intervention compared to alternatives such as transurethral resection of the prostate, serious adverse events have been reported to occur including death. Our findings can provide learning points for surgeons and allow for improved patient counselling and treatment planning accordingly.

Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database.

Radiofrequency ablation (RFA) is a relatively novel, increasingly popular treatment option for leiomyomas. We studied medical device-related reports of leiomyoma RFA devices to determine whether there are emerging device-related issues. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried from 2012 through November 2022. Sixty unique reports, including adverse events and device malfunctions, were analyzed for both laparoscopic and transcervical RFA devices. Forty-three injury reports were reviewed. The most common adverse event was infection. Of the injury cases, 34.9% required additional surgical intervention. Although the details of each event are limited, these reports highlight the importance of postmarket surveillance of new technologies and the necessity of improving the current system of implementation and monitoring.

Microwave energy devices for hyperhidrosis are associated with infections, neurologic symptoms, and burns in a retrospective analysis of the Manufacturer and User Facility Device Experience database 2013-2022

Microwave energy devices for hyperhidrosis are associated with infections, neurologic symptoms, and burns in a retrospective analysis of the Manufacturer and User Facility Device Experience database 2013-2022

Guest Editorial: Advanced Intelligent Manufacturing System: Theory, Algorithms, and Industrial Applications

Intelligent manufacturing has promoted the development of Industry 4.0 and enabled the manufacturing industry to gradually move into the stage of intelligence with the rapid development of the Internet of Things and the Industrial Internet. An intelligent manufacturing system is a manufacturing system that can automatically adapt to changing environments and varying process requirements with minimal supervision and assistance from operators. Therefore, intelligent manufacturing has become a recognized core high technology to enhance the overall competitiveness of the manufacturing industry. The goal of intelligent manufacturing is to make production resources form a circular network with the characteristics of autonomy, adjustability, and configurability, to develop production processes flexibly, and to realize the efficiency of individual customization. For example, by analyzing the factory floor data, equipment monitored data, and the enterprise manufacturing database, it could help to store, explore, and make complex decisions for the manufacturing system. To achieve this goal, modern information technologies, such as artificial intelligence, big data, cloud computing, and mobile Internet, modeling, control, and optimization need to be integrated and collaborated with the physical resources of the manufacturing process, which triggers new theory, solution algorithms, and application scenarios.

Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review.

MAUDE database houses medical device reports of suspected device-related complications received by Food and Drug Administration. In the present study we aim to evaluate the MAUDE database for reported complications of MIST procedures. The database was queried using keywords: rezum, urolift, prostate embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), prostate stent and Temporarily Implanted Nitinol Device (iTIND) on 10/1/22 to extract information regarding device problems and procedure-related complications. Gupta classification system was used to stratify complications. Statistical analysis was performed to compare frequency of complications among MIST procedures. We found a total of 692 reports (Rezum-358, urolift-226, PAE-53, TUNA-31, TUMT-19, prostatic stent-4, and iTIND-1). Most complications related to device or users were minor (level 1 and 2) and there was no significant difference among various MIST procedures. The screen/system error was responsible for 93% and 83% aborted cases in Rezum and TUNA, respectively, and PAE showed 40% of device component detachment/fracture. Overall Urolift and TUMT were associated with statistically significant higher incidence of major (level 3 and 4) complications (23% and 21%, respectively) as compared with Rezum (7%). Most major complications needing hospitalization after Urolift included hematoma and hematuria with clots and those after Rezum included urinary tract infection and sepsis. Thirteen deaths were reported, mostly due to cardiovascular events, which were classified as not associated with the proposed treatment. MIST for BPH can occasionally cause significant morbidity. Our data should assist urologists and patients in shared decision-making process.

EDITORIAL COMMENT Re: Device Failure and Adverse Events Related to Single-use and Reusable Flexible Ureteroscopes: Findings and New Insights From an 11-Year Analysis of the Manufacturer and User Facility Device Experience Database. Urology. 2023 Jul;177:41-47

We are accustomed to embracing new technology with a bit of hype, and reviewing its pro's while in trend. However, innovations that don't stand the test of time tend to disappear into thin air, leaving no trace of the details leading to their ill fate. Pat Jones et al. have touched the much anticipated area of timely health technology assessment, reflecting on newly available single-use flexible ureteroscopy (fURS) equipment, by accessing post-marketing data from a crowd-sourced database. Accessed March 20, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device

The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN) is a peripheral arterial disease management system that was recalled in December 2021 secondary to repeated guidewire prolapse. We set forth to analyze the patient problems and device issues that caused the device to be recalled and determine if the recall had a significant impact on the device reports utilizing the US Food and Drug Administration (FDA) database Manufacturer and User Facility Device Experience (MAUDE). MAUDE was queried for all adverse report events for the HawkOne device six months prior to and after its recall date in December 2021. Data collected included patient-based issues, device-based issues, and if the device was evaluated by the manufacturer. Fisher's exact test was utilized. There were 72 unique events reported prior to the device recall and 35 events reported after the recall. The majority of adverse events resulted in no adverse clinical outcomes before (55.6%) and after (21.3%) the recall. The most common reported device issue was detachment both before (54.8%) and after (57.1%) the recall. There was no significant difference in the rate of any patient outcome or device problem after the recall. The number of devices evaluated by the manufacturer after the recall was significantly reduced (69.9% vs 11.4%; P ≤ .001). There was no significant change in the rate of specific patient outcomes or device issues after the HawkOne device recall. The rate at which the devices were evaluated by the manufacturer significantly reduced after the recall. These data indicate possible influences that an official device recall might have on reporting to the MAUDE and warrant further study to understand the complexity of user-based feedback of such endovascular devices.

PO-02-227 ADVERSE EVENTS ASSOCIATED WITH AUTOMATIC EXTERNAL DEFIBRILLATOR - LIFEPAK: A STUDY FROM FOOD AND DRUG ADMINISTRATION MAUDE DATABASE

Automatic External defibrillator (AED) can analyze heart rhythms and allows operators to deliver treatment in patients with tachyarrhythmias or cardiac arrest with a shockable rhythm. The incidence of adverse events (AE) between different ED models is not well known. We sought to assess the type of AE associated with the AED – Lifepak series (Stryker, Kalamazoo, MI) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received between January 1992 to October 2022 to capture all AE. A total of 32,557 AE were reported from 1992 to 2022. An increase in trends of AE was observed from 1992 to 2022 (0.1% to 7.3%), respectively. Among the 7 Lifepak models, Lifepak CR Plus (5.5%, 1177 events), Lifepak CR2 (5.7%, 1230 events), and Lifepak 20e (5.85%, 1260 events) had the three lowest reported AE while the Lifepak 15 (28.2%, 6073 events), Lifepak 20 (21.2%, 4561 events) and Lifepak 12 (23.6%, 5085 events) had the three highest reported AE (21,503 events). The most commonly reported AE was product malfunction (95.9%, 31,209 events) resulting in patient injury (0.9%, 289 events) and patient death (2.9%, 950 events). Correct utilization of AED is crucial during advanced cardiac life support. Appropriate selection of AED models with clinical situations and operators’ experience is essential.

Clinical Adverse Events and Device Failures Reported for the Captivator and Duette Endoscopic Mucosal Resection (EMR) Systems: A MAUDE Database Analysis.

Endoscopic mucosal resection (EMR) is a widely used technique for the removal of precancerous or select cancerous mucosal-based lesions. Two systems used for EMR of upper gastrointestinal lesions are the Duette EMR kit and the Captivator EMR kit. The aim of this study is to analyze the reports submitted to the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for patient-related adverse events and device failures associated with these EMR kits. We analyzed postmarketing data from the FDA MAUDE from August 2004 to August 2021. Eighty-four MAUDE reports were found in the study period from August 2004 to August 2021. In total, device issues comprised 36.9% of the reports (n=31) and patient adverse events comprised 63.09% of the reports (n=53). Device issues that were reported included, but were not limited to, band placement/deployment failure (8.1%), suture breakage (7.31%), and snare breakage (4.94%). Patient adverse events that were reported included, but were not limited to, bleeding (25.9%), perforation (7.31%), and snare breakage (4.94%). Captivator EMR and Duette EMR have similar patterns of technical failure and clinical adverse events. More MAUDE reports exist for Duette EMR, possibly due to its longer duration of commercial availability.

MP-453087-5 ADVERSE EVENTS ASSOCIATED WITH AVEIRTMVR LEADLESS PACEMAKER: A FOOD AND DRUG ADMINISTRATION MAUDE DATABASE STUDY

Since the first pacemaker implantation, much of the effort has been focused on battery longevity and device miniaturization. Leadless pacemaker offers an innovative approach to the treatment of bradyarrhythmias, thus avoiding long-term lead-related complications. Recently, the Aveir (screw-in type leadless pacemaker) (Abbott) has been approved by the Food and Drug Administration (FDA). We queried the FDA Manufacturer And User Facility Device Experience (MAUDE) database to study the safety profile and assess the types of complications with this relatively novel device technology. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received post-FDA approval to capture all adverse events. A total of 42 events (after removing duplicate entries or programmer or introducer sheath-related issues n=13) were reported for Aveir leadless pacemaker post-FDA approval. The most frequently reported issue was a device malfunction-related event (n=36, 85.7%). The most commonly encountered problem was the capture issue (28.6%, 12 events), followed by the sensing issue (19%, 8 events), high impedance (19%, 8 events), stretched helix (19%, 8 events), device dislodgement (14.3%, 6 events), device separation failure (14.3%, 6 events), premature separation (4.8%, 2 events), material twist (4.8%, 2 events), and broken helix (2.4%, 1 event). As such, this resulted in pericardial effusion requiring pericardiocentesis (9.5%, 4 events), cardiac perforation (9.5%, 4 events), and arrhythmia (2.4%, 1 event). This resulted in one death. Aveir leadless pacemaker implantation may be complicated by myocardial perforations and tears that result in cardiac tamponade and death. Our study is limited by heterogeneity in reporting, and lack of assessment of the total number of cases performed per year; thus, warranting better transparency and monitoring mechanisms.

PO-05-084 MANAGEMENT OF GRADUAL ELEVATED SHOCK IMPEDANCE IN ENDOTAK RELIANCE ICD LEADS

Elevated shock impedance might indicate structural compromise to implantable cardioverter-defibrillator (ICD) leads. Defibrillation or shock impedance can be measured in two ways: through high output therapy termed true shock impedance (TSI); or through a calculated value using a low voltage sub-threshold measurement (LVSM). We have identified 3 cases of gradual LVSM shock impedance rises (>130 ohm) in patients with Endotak Reliance ICD leads at our institution who subsequently had an open circuit fault code at commanded TSI testing. Literature search revealed case series (Hauser RG et al 2020 and Monkhouse C et al 2019) highlighting this phenomenon. We sought to understand the scope and establish potential recommendations for commanded shock TSI testing in patients with Endotak Reliance ICD leads and high LVSM shock impedance by reviewing cases reported in the FDA Manufacturer and User Facility Device Experience (MAUDE) database. We searched the MAUDE database from 2008 to 2021 for “high impedance” or “impedance problem” while filtering for Endotak Reliance ICD leads. Of these 1369 patients, we identified those who underwent commanded shock testing. The MAUDE search identified 117 ICD leads with high shock impedance (majority > 125 ohm) that underwent DFT or commanded shock. Of those, 69 (59%) had successful DFT or what was deemed as acceptable impedance after commanded shock and remain in service. 18 dual coil leads (15%) underwent shock vector change prior to testing with 16 (87%) of those remaining in service. 30 (26%) of the leads had open circuit fault code, continued high shock impedance or failed defibrillation with testing. These leads were extracted or abandoned with new leads implanted. 1 death was reported as a complication of lead extraction. Endotak Reliance ICD leads can show gradual rise in LVSM shock impedance although the etiology is uncertain. Potential theories include fibrotic encapsulation or calcification of the SVC/RV coil. It is important that these patients are identified, monitored, and risk stratified. We recommend high voltage TSI commanded shock testing in high-risk patients with a gradual rise in LVSM shock impedance that is above the acceptable range. If the impedance is within normal limits during testing, continued surveillance might suffice with repeat testing if further increase in impedance is observed. If the impedance remains elevated with TSI commanded shock testing, then lead replacement should be considered.

A-8 | Modes of Failure of Guide Catheters Extensions: Insights from the Manufacturer and User Facility Device Experience (MAUDE) database

A-8 | Modes of Failure of Guide Catheters Extensions: Insights from the Manufacturer and User Facility Device Experience (MAUDE) database