Ring Suture Research Articles

Does percutaneous internal ring suturing contain risk of ilioinguinal nerve entrapment?

In this study, we aim to assess the alteration of IIN functions in children with inguinal hernias operated on using open or 'percutaneous internal ring suturing' (PIRS). This study was based on a prospective clinical trial of 60 pediatric patients. They were operated on using PIRS or conventional open hernia repair technique. Group 1 included 35 patients who were treated with PIRS technique. Group 2 included 22 patients who underwent a conventional open hernia repair. The ilioinguinal nerve stimuli in both the operational and non-operational areas were evaluated in patients with peripheral EMG for possible ilioinguinal nerve damage on the hernia side before the operation and to reevaluate ilioinguinal nerve function in the third postoperative week. In Group 1, 19 cases underwent a preoperative EMG examination and in 35 cases, EMG examination was obtained postoperatively. Pre- and postoperative EMG results were normal in all cases in Group 1 on both the operational and non-operational sides. In Group 2, 15 preoperative and 25 postoperative EMG examinations were obtained. In Group 2, only one case with a right inguinal hernia who had normal preoperative EMG results showed no IIN response in a postoperative EMG evaluation obtained in the third postoperative week, with a normal left-side response. The EMG was repeated at the three-month postoperative third mark and revealed the same result. In a six-year-old female case, there was a negative EMG response on the non-operative side both pre- and postoperatively.

Transcatheter aortic paravalvular leak closure using 3 Amplatzer Vascular Plug III devices in a child.

Paravalvular leak (PVL) is usually related to disruption of prosthetic valve sewing ring sutures. Many previous reports have described transcatheter paravalvular leak closure in adult patients [1–4], but those describing such a procedure in children are scarce. A 16-year-old boy underwent an aortic valve replacement (AVR) with a stented bioprosthesis Hancock 23 mm due to combined aortic stenosis and insufficiency. Soon after, a significant paravalvular leak was detected and initially managed medically. However, within the next 5 months the patient became breathless on exertion and developed significant left ventricular dilatation. Paravalvular leak closure was performed under general anesthesia, with transesophageal echocardiographic (TEE) and angiographic guidance. Aortography confirmed grade 3 aortic regurgitation (Figure 1A). The paravalvular leak size was evaluated in TEE at 4 × 3 mm. It was identified as posterior, from the noncoronary Valsalva sinus into the left ventricle (LV). The defect was easily crossed using two JR catheters and hydrophilic wires, then Amplatz extra-stiff guidewires were introduced from both femoral arteries into the LV. Over these, 120 cm long sheaths (6 Fr and 7 Fr) were advanced through the paravalvular leak. No obstruction during the crossing was met, which was considered confirmatory of the defect size exceeding what was expected from TEE. Accordingly, the decision was taken to implant 3 devices in order to avoid a residual shunt. Two 8/4 Vascular Plugs type III were implanted and one 6/3 mm Vascular Plug type III (St Jude Medical Inc.). After sequential opening of the distal discs in the LV all plugs were withdrawn simultaneously to the level of the paravalvular leak orifice. The proximal discs were then opened (Figure 1B) with immediate complete closure of the shunt on TEE (Figure 1C). Prior to devices release, proper function of the prosthetic valve was confirmed by TEE. Control aortography showed proper position of devices without Ao–LV shunt (Figure 1D). Fluoroscopy time was 18.5 min. The next morning the patient underwent transthoracic echocardiography which confirmed a good procedure result with normal function of the prosthetic aortic valve, without any regurgitant jet. The patient was discharged 3 days after the procedure on 150 mg Aspirin q.d. Figure 1 A – Aortography RAO 30 Caud 30. Paravalvular leak from posterior Valsalva sinus to LV. B – Three Amplatzer Vascular Plug 3 devices closing paravalvular leak still connected with delivery system. C – Transesophageal echocardiographic ... Early mortality in redo AVR reaches 3.5–6% [1]. Transcatheter treatment has been constantly developing during the last years. Transcatheter PVL closure was initially performed with devices dedicated to patent ductus arteriosus, ventricular septal defect and atrial septal defect [2]. In our and others’ opinion, especially useful for such purposes is Amplatzer Vascular Plug type III [3]. Lack of internal fabric, which could potentially promote clot formation, may be considered a major disadvantage of the device. We suspect that use of one or two bigger plugs in the hereby-presented case might result in residual leaking and possibly hemolysis [4]. To avoid such complications we chose 3 plugs to ensure tight as possible filling of the defect. Simultaneous implantation of multiple devices increases the chance of final success, which was described previously [3].

Suture Forces in Undersized Mitral Annuloplasty: Novel Device and Measurements

To demonstrate the first use of a novel technology for quantifying suture forces on annuloplasty rings to better understand the mechanisms of ring dehiscence. Force transducers were developed, attached to a size 24 Physio ring, and implanted in the mitral annulus of an ovine animal. Ring suture forces were measured after implantation and for cardiac cycles reaching peak left ventricular pressures (LVP) of 100, 125, and 150 mm Hg. After implantation of the undersized ring to the flaccid annulus, the mean suture force was 2.0±0.6 N. During cyclic contraction, the anterior ring suture forces were greater than the posterior ring suture forces at peak LVPs of 100 mm Hg (4.9±2.0 N vs 2.1±1.1 N), 125 mm Hg (5.4±2.3 N vs 2.3±1.2 N), and 150 mm Hg (5.7±2.4 N vs 2.4±1.1 N). The largest force was 7.4 N at 150 mm Hg. The preliminary results demonstrate trends in annuloplasty suture forces and their variation with location and LVP. Future studies will significantly contribute to clinical knowledge by elucidating the mechanisms of ring dehiscence while improving annuloplasty ring design and surgical repair techniques.

Prosthetic Valve Strands

A 62-year-old woman presented with a sudden transient ischemic attack (TIA). Symptoms resolved within 2 hours of onset. Neurological evaluation and workout for etiology of the TIA was unremarkable. Her medical history included having a St. Jude mitral valve replacement for mitral regurgitation 10 years before presentation. The patient had been maintained on warfarin with INR levels generally in the 3.2–3.6 range. There was no history of atrial dysrhythmia. The admission electrocardiogram was normal. Transthoracic echocardiography (TTE) (Toshiba America, Tustin, CA) was unremarkable except for a mildly enlarged left atrium (LA) measuring 43 mm, with normal left ventricular systolic function noted. The St. Jude mitral prosthesis functioned normally with a normal diastolic gradient. Transesophageal echocardiography (TEE) was performed to evaluate for a cardiac source of embolism. The thoracic aorta was normal and there was no intracardiac shunt detected with saline contrast injections via the antecubital vein. Spontaneous echo contrast was noted near the mouth and within the left atrial appendage, but no thrombus was found. The prosthetic mitral valve was found to function normally, demonstrating a color Doppler short-duration diverging “V” pattern of small nonturbulent “flames” of backflow in the LA during systole (movie clip S1). Multiple mobile filamentous linear echo dense structures were noted within the LA, attached to the prosthetic valve (Fig. 1 and movie clip S2). Based on these TEE findings, a recommendation was made to aggressively maintain an INR > 3 and add lowdose aspirin. Valve strands have been noted since the advent and routine clinical use of TEE. They are linear echo dense structures attached to the mechanical valve and are usually 1–2 mm in width and several mm in length. In distinction, sewing ring sutures are shorter, brighter, and spaced in regular intervals around the ring. Microbubbles are also highly mobile echoes, but move away from the valve during leaflet closure. Valve strands may be associated with native or prosthetic heart valves, and appear to be relatively common, most often attached to mechanical mitral valves. One study (n = 182) found strands in 26% of all patients with an artificial heart valve, with a prevalence of 27% in mechanical and 8% in bioprosthetic valves. By location, they occurred in 32% of mitral and 13% aortic prosthetic valves. Another large study of patients with mechanical heart valves (n = 283) found strands in 38% of prosthetic valves, most often those in the mitral position. Valve strands are likely associated with systemic embolic events. It has been postulated that they may be a marker of inadequate anticoagulation or be indicative of a “pro-thrombotic” state. Strands tend to be associated with older

Laparoscopic inguinal hernia repair in children using the percutaneous internal ring suturing technique - own experience.

IntroductionPercutaneous internal ring suturing (PIRS) is a method of laparoscopic herniorrhaphy, i.e. percutaneous closure of the internal inguinal ring under the control of a telescope placed in the umbilicus.AimTo evaluate the usefulness of the PIRS technique.Material and methodsFifty-five children (39 girls and 16 boys) underwent surgery using this method in our institution between 2008 and 2010.ResultsIn 10 cases the presence of an open inguinal canal on the opposite side was also noted during surgery, and umbilical hernia was recognized in 2 patients. In 5 cases it was necessary to convert to the open surgery because of the inability to continue the laparoscopic procedure. In 1 case, male pseudohermaphroditism was diagnosed during surgery. Recurrent inguinal hernia required a conventional method of surgery in 1 child. Other children did not exhibit the characteristics of hernia recurrence. The inguinal canals were followed up with postoperative ultrasound examination in 29 children. In 23 children, the ultrasound examination showed no dilatation of the inguinal canal. In the other 6 children dilatation of the inguinal canal or the presence of fluid within the inguinal canal was observed during ultrasound. In 6 children symptoms such as swelling and soreness around the inguinal canal developed within 3 to 6 months after surgery.ConclusionsInguinal hernia surgery using the PIRS procedure is an alternative, effective, minimally invasive method of surgery. Visualization of the peritoneal cavity allows for detection of other abnormalities, as well as for performing other procedures during the same session (such as closing the contralateral inguinal canal or umbilical hernia surgery).

New Technique of Intracorneal Ring Segments Suturing After Migration

To describe a new technique for suturing of the intracorneal ring segments to stabilize it in the proper location and to prevent recurrent displacement of the ring. Two patients with recurrent ring segment migration toward the incision were treated with this new surgical technique between 2010 and 2013. The first case had Intacs ring (Addition Technology, Fremont, CA) and migration occurred 2 months after implantation. The second case had Keraring segment (Mediphacos, Belo Horizonte, Brazil) and migration occurred 1 week postoperatively. The ring segments were fixated to the cornea with a 10-0 nylon suture through the channel. The suture was removed at 1 month postoperatively. Ring segments remained in the desired location with a follow-up period of at least 6 months after implantation. This newly described ring suturing technique is an effective procedure that can be used to treat ring segment migration in the channel.

The Influence of Suture Density on Bioprosthetic Heart Valve

This paper constructs the parametric model of the spherical heart valve via computer aided design, a series of accurate parameters of the bioprosthetic heart valve, such as the radius of the sutural ring, height of the supporting stent and inclination of the supporting stent are determined. The finite element method is used to determine the effect of the suture density on the dynamic properties of the bioprosthetic heart valve. The finite element analysis results show that the suture has a significant effect on the dynamic properties of the leaflets. The peak stress with different suture density is quite different and the stress distribution with higher suture density is more reasonable than that with lower suture density. In addition, the suture density has more effect at the top of the attachment edge than the other parts of the valve leaflets. This work is very helpful to manufacture the bioprosthetic heart valve with long term durability.

CT attenuation measurements are valuable to discriminate pledgets used in prosthetic heart valve implantation from paravalvular leakage

Sutures with polytetrafluorethylene (PTFE) felt pledgets are commonly used in prosthetic heart valve (PHV) implantation. Paravalvular leakage can be difficult to distinguish from PTFE felt pledgets on multislice CT because both present as hyperdense structures. We assessed whether pledgets can be discriminated from contrast-enhanced solutions (blood/saline) on CT images based on attenuation difference in an ex vivo experiment and under in vivo conditions. PTFE felt pledgets were sutured to the suture ring of a mechanical PHV and porcine aortic annulus, and immersed and scanned in four different contrast-enhanced (Ultravist®; 300 mg jopromide ml(-1)) saline concentrations (10.0, 12.0, 13.6 and 15.0 mg ml(-1)). Scanning was performed on a 256-slice scanner with eight different scan protocols with various tube voltage (100 kV, 120 kV) and tube current (400 mAs, 600 mAs, 800 mAs, 1000 mAs) settings. Attenuation of the pledgets and surrounding contrast-enhanced saline were measured. Additionally, the attenuation of pledgets and contrast-enhanced blood was measured on electrocardiography (ECG)-gated CTA scans of 19 patients with 22 PHVs. Ex vivo CT attenuation differences between the pledgets and contrast-enhanced solutions were larger by using higher tube voltages. CT attenuation values of the pledgets were higher than contrast-enhanced blood in patients: 420±26 Hounsfield units (mean±SD, range 383-494) and 288±41 Hounsfield units (range 202-367), respectively. PTFE felt pledgets have consistently higher attenuation than surrounding contrast-enhanced blood. CT attenuation measurements therefore may help to differentiate pledgets from paravalvular leakage, and detect paravalvular leakage in patients with suspected PHV dysfunction.

Influence of Material Thickness to the Dynamic Mechanical Properties of Bioprosthetic Heart Valve

The paper constructs one type of bioprosthetic valve leaflets’ parametric model via computer aided design, a series of accurate parameters of the bioproshtetic heart valve, such as radius of the sutural ring, height of the supporting stent and inclination of the supporting stent, are determined. Numerical simulation is used to determine the effect of one shape design on the mechanical performance of the bioprosthetic valve leaflet. The stress with a shape under the same load is analysed and the thickness of the leaflets 0.5mm and 0.6mm is compared by us. We creat a ellipsoidal surface in accordance with geometrical features. The experimental results of the finite element analysis show that stress distribution of the same bioprosthetic heart valve leaflets with different thickness is different. The maximal primary stress with the thickness of 0.5mm is lower than the others. This work is very helpful to manufacture reasonable shaped valvular leaflets and to prolong the lifetime of the bioprosthetic heart valve.

The Geometric and Material Nonlinear Analysis of the Bioprosthetic Heart Valve

This paper constructs four types of bioprosthetic heart valve’s parametric model via computer aided design, a series of accurate parameters of the bioprosthetic heart valve, such as radius of the sutural ring, height of the supporting stent and inclination of the supporting stent are determined. The finite element method is used to analyze the mechanical properties of the bioprosthetic heart valve in which geometric non-linearity and material non-linearity are all taken into account. The finite element analysis results show that the shape of the bioprosthetic has a significant effect on the mechanical performance of the valve. The stress distribution of ellipsoidal valve leaflets is comparatively reasonable. It has lower peak von-Mises, smaller stress concentration area than the other three types of valve leaflets. This work is very helpful to manufacture valvular leaflets with reasonable shapes and to prolong the lifetime of the bioprosthetic heart valve.

Dynamic Analysis of the Bioprosthetic Heart Valve on Different Fixation

This paper constructs the bioprosthetic valve leaflets’ parametric model via computer aided design, a series of accurate parameters of the bioproshtetic heart valve, such as such as radius of the sutural ring, height of the supporting stent and inclination of the supporting stent, are determined. Numerical simulation is used to determine the effect of different shape designs and attachment edge fixed ways on the mechanical performance of the bioprosthetic valve leaflet. The dynamic behavior of the valve during diastolic phase is analyzed. The finite element analysis results show that the stress distribution of the ellipsoidal leaflet valve is comparatively reasonable. The ellipsoidal leaflet valve has the following advantages over the cylindrical leaflet valve, lower peak von Mises-stress, smaller stress concentration area, and relatively uniform stress distribution. The different ways of the attachment edge fixed also have a significant effect on the dynamic behavior of the valve. Attachment edge with some degrees of rotation when seamed to the stent can act to reduce the pressure and make the stress distribution reasonable. Reasonable attachment edge fixation may contribute to the long term durability of the valve. This indicates the need to account for the attachment edge seamed way, when manufacturing the bioproshetic heart valve with long term durability. This work is very helpful to manufacture valvular leaflets with reasonable shapes and to prolong the lifetime of the bioprosthetic heart valve.

Biventricular Circulatory Support With Two Miniaturized Implantable Assist Devices

Up to 30% of patients with end-stage heart failure experience biventricular failure that requires biventricular mechanical support. For these patients, only bulky extracorporeal or implantable displacement pumps or the total artificial heart have been available to date, which enables only limited quality of life for the patients. It was our goal to evaluate a method that would allow the use of 2 implantable centrifugal left ventricular assist devices as a biventricular assist system. Seventeen patients have been implanted with 2 HeartWare HVAD pumps, 1 as a left ventricular assist device and 1 as a right ventricular assist device. Seventy-seven percent of the patients had idiopathic dilated or ischemic cardiomyopathy. Their age ranged from 29 to 73 years (mean 51.8 ± 14.5 years), and 11 (64.7%) received intravenous catecholamine support preoperatively. The right ventricular assist device pump was implanted into the right ventricular free wall. The afterload of this pump was artificially increased by local reduction of the outflow graft diameter, and the effective length of its inflow cannula was reduced by the addition of two 5-mm silicon suture rings to the original HVAD implantation ring. All right ventricular assist device devices could be operated in appropriate speed ranges and delivered a flow of between 3.0 and 5.5 L/min. Thirty-day survival was 82%, and 59% of the patients could be discharged home after recovering from the operation. There was no clinically relevant hemolysis in any of the patients. Two HeartWare HVAD pumps can be used as a biventricular assist system. This implantable biventricular support gives the patients more comfort and mobility than usual biventricular ventricular assist devices with large and noisy displacement pumps.

Dynamic Analysis of Three Types of Bioprosthetic Heart Valves

This paper constructs three types of bioprosthetic valve leaflets’ parametric model via computer aided design, a series of accurate parameters of the bioproshtetic heart valve, such as radius of the sutural ring, height of the supporting stent and inclination of the supporting stent, are determined. Numerical simulation is used to determine the effect of different shape designs on the mechanical performance of the bioprosthetic valve leaflet. The dynamic behavior of the valve during diastolic phase is analyzed. The finite element analysis results show the stress distribution of the ellipsoidal and spherical valve leaflets are comparatively reasonable. The ellipsoidal and spherical valve leaflets have the following advantages over the cylindrical leaflet valve, lower peak von-Mises stress, smaller stress concentration area, and relatively uniform stress distribution. The ellipsoidal and spherical valve leaflets may contribute to the long term durability of the valve. This work is very helpful to manufacture valvular leaflets with reasonable shapes and to prolong the lifetime of the bioprosthetic heart valve.

Evaluation of the HeartWare HVAD Centrifugal Pump for Right Ventricular Assistance in an In Vitro Model

We have developed a method that allows the use of a commercially available implantable left ventricular assist device (LVAD; HeartWare HVAD) for right ventricular (RV) assistance. A mock circulation was used to examine the flow characteristics of the system with different outflow diameters (10-4 mm). Furthermore, we looked for a material for safe and satisfactory reduction of the effective length of the inflow cannula for better fitting to the RV dimensions. Reduction of the outflow graft to an inner diameter of ∼5 mm adds as much resistance to the system that in patients with a normal pulmonary resistance, the pump would deliver between 3.5 and 7 L/min. We added two 5 mm silicon suture rings to the system's "apical" sewing ring to reduce the effective length of the inflow cannula. Connection of the pump to the anterior free wall of the right ventricle ensures good orientation of the inflow cannula within the RV cavity, with sufficient space to prevent the inflow cannula from suction to the opposite interventricular septum. The HeartWare LVAD pump seems also to be usable as a right ventricular assist device (RVAD) after a few, but important, modifications of the implant procedure.

Mitral valve repair in a patient with previous percutaneous annuloplasty with a CARILLON device

A 67-year-old female patient was referred to our clinic for coronary artery bypass graft and severe mitral regurgitation (MR) treatment. The patient had a history of coronary disease and MR treated in 2007 with a CARILLON device. Left mammary and saphenous vein were used to graft the diseased coronaries. MR was corrected with a saddle ring; however, we had some difficulties anchoring ring sutures to the mitral annulus caused by the protruding CARILLON. The ring was finally stitched, and the patient was weaned from bypass. A transoesophageal echo showed a competent valve. The patient was transferred to the intensive care unit on moderate catecholamines.

The Abdominal Smile Sign

A 72-year-old man status post cholecystectomy, prostatectomy with residual surgical clips (black arrow), and right hemicolectomy with suture ring (white arrow) presented to the emergency department after “choking on something” while taking his morning pills. He described no chest pain, abdominal pain, dysphagia or dyspnea, but could not find his dental bridgework. A KUB revealed partial dentures in his lower abdomen. By comparing the KUB with an unrelated abdominal CT scan, radiology determined that the dentures were no longer in the stomach. Indications for endoscopic removal of sharp foreign bodies, such as dentures, include location of the object in the esophagus or stomach. Swallowed objects that enter the stomach will typically pass without incident; however, complications have been noted in up to 35% of patients. Impaction, perforation, or obstruction most commonly occurs at areas of acute angulation, including the ileocecal valve. In cases where the object cannot be removed safely, patients should be monitored with daily radiographs. Surgery should be considered if the object does not progress through the gastrointestinal tract within three days. In this case, the patient returned for daily imaging and passed the dentures on day three without pain. After a thorough cleaning, the patient continues to wear his dentures, despite his wife’s protests.

Deep-seated structure and metallogenic dynamics of the Ailaoshan polymetallic mineralization concentration area, Yunnan Province, China

The Ailaoshan poly-metallic mineralization concentrated area (MCA) consists of the well known Ailaoshan metallogenic belt and adjacent mineral districts and/or deposits. Located in an area of several complex and intersecting tectonic units, the Ailaoshan poly-metallic MCA is controlled by deep crustal and mantle tectonism. Through interpretation of remote sensing images, we identified a largering structure system that surrounds the MCA. This ring structure encloses regional deep-crustal faults, ductile shear zones, geothermal anomalies, magmatic rocks, and the major mineral deposits, all of which are the reflections of deep tectonic geodynamics that have been long active in this area. Geophysical data indicate that the crust is comprised of relatively stable two or three layers, with some irregular lower-velocity belts. The Moho in the ring sutures occurs as an area of local uplift. There exists an obvious transitional zone between the crust and mantle boundaries. Asthenopheric mantle shows multi-layer upwelling, which indicates multiple events during different geological epochs. It is believed that these mantle events or pulses were responsible for the formation of the regional shear zones, magmatic rocks, and polymetallic orebodies. Furthermore, an integrated metallogenic dynamics model related to the asthenopheric upwelling pulses in the MCA is established, defining events as old as Late Paleozoic.

Decreased Recurrence Rate in the Laparoscopic Herniorraphy in Children: Comparison Between Two Techniques

The laparoscopic herniorraphy in children is still associated to a high recurrence rate. The aim of this study was to assess whether the addition of the lateral incision of the sac to the sole suture of the inner inguinal ring could reduce the recurrence rate. A retrospective review was performed of the collected data of 248 laparoscopic inguinal hernia repairs in 224 children (175 males, 49 females) between 8 months and 11 years of age (mean age, 5 years; median, 4) in our institution from January 2004 to December 2007. The hernia was unilateral in 204 patients (133 on the right side, 71 on the left) and bilateral in 20 patients. A 5-mm umbilical camera port for a 0-degree laparoscopic optics and two operative 2- or 3-mm reusable trocars inserted in the lower right and left quadrants of the abdominal wall were utilized. In a group of 123 patients, the inner inguinal ring was closed, adopting a W-shaped suture (inguinal ring suture; IRS). In the other group of 101 patients, a lateral incision of the sac of 1-2 cm was carried out before the W-shaped suture of the inner inguinal ring (inguinal ring incision suture; IRIS). At a mean follow-up of 24 months (range, 6-36), 5 of 133 (3.76%) hernias recurred between 6 and 12 months after surgery in the IRS group. In the IRIS group, none of the patients presented with recurrence. The rate of recurrences in the two groups was compared and analyzed with the x2 test. The resulting difference was statistically significant (P < 0.05). In our experience, the incision of the peritoneum lateral to the internal inguinal ring and the W-shaped suture, compared to the sole W-shaped suture, is safe and effective in preventing hernia recurrence.

Local Erosions of a Bioprosthetic Aortic Valve Cusp Caused by Towering Ring Suture Knots Too Close to the Valve

A 75-year-old patient was referred to our clinic with the diagnosis of a grade III paravalvular aortic valve regurgitation 5 years after bioprosthetic aortic valve replacement with the SJM EPIC Valve bioprosthesis (St. Jude Medical Inc, St. Paul, Minn). During …

Vorkommnismeldungen bei mechanischen Herzklappenprothesen

The purpose of this study was to collect the experience gained from risk assessment of incidents associated with mechanical heart valves as reported to the German Medical Devices Vigilance System. All events in connection with the use of prosthetic heart valves which had been reported to the Federal Institute for Drugs and Medical Products were identified in the Institute's anonymized database. Subsequently all information that had been obtained and the reports of investigations by the various responsible manufacturer of medical products were retrospectively analysed. Of 53 incident reports the aortic valve position was involved 32 times, the mitral valve position 21 times. 17 cases of leaflet breakage, 12 of leaflet dysfunction, 6 of valve thrombosis, 4 of paravalvular leakage, 4 of damage to the suture ring, 3 of endocarditis and 7 of various other singular defects were reported. The outcome was mostly very serious (re-surgery, prolongation of surgery, death). Corrective actions taken by the manufacturers consisted of recalls, advisory notices and stoppage of production. The Medical Devices Vigilance System is able to detect product failures of mechanical heart valves and to initiate corrective action. As the reporting rate over more than 10 years is relatively low, it can be assumed that in general mechanical heart valves are safe medical devices. The quality of incident reporting by manufactures and users of medical devices should be improved to reduce the number of undetected and unsolved incidents.