MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number 3000

Device Problems Calcified (1077); Degraded (1153); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

The carpentier-edwards pericardial valve has been designed to minimize structural valve deterioration (svd).Excellent durability and low incidence of valve-related complications have been reported in the literature.Despite the low incidence of valve-related complications, it is well known bioprosthetic tissue valves can deteriorate with time and eventually fail.As noted in the literature, the rate of svd in bioprosthetic valves increases over time, particularly after the initial 7 to 8 years after implantation.Regurgitation, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Svd is the most common reason for bioprosthesis explants/replacements and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.In this case, there was a reported torn leaflet, which was likely the result of svd.The reported event cannot be confirmed.The device has not been returned for evaluation.However, this event most likely impacted by the progression of the patient¿s underlying valvular disease pathology with svd.There was no indication or allegation of a device malfunction and/or deficiency contributing to the event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.In this case, it was learned that this male patient with a bioprosthetic aortic valve, implanted for nine (9) years and nine (9) months, underwent redo aortic valve replacement due to a torn leaflet which lead to sever aortic insufficiency.He received a new edwards bioprosthetic valve in replacement.He tolerated the procedure well and was transferred to the icu postoperatively.Postoperatively, the patient had a complete heart block and received a permanent pacemaker.He was discharged on pod #7.

Manufacturer Narrative

Device evaluated by manufacturer: the clinical observation of torn leaflet was confirmed.Report of insufficiency was visually confirmed due to torn leaflet.As received all three leaflets had cut sections, which measured approximately 11mm x 3mm on leaflets 1 and 2, and 12mm x 4mm on leaflet 3.The cuts had smooth and even edges; cut sections were not returned.X-ray demonstrated wireform intact, minimal calcification on the remaining sections of leaflet 1, and moderate calcification on the remaining sections of leaflets 2 and 3.Serrated markings were observed on the outflow aspect of leaflet 2.Leaflet 2 had two tears of approximately 5mm along commissure 2, and 10mm along commissure 3.Calcification was evident near the tears.Host tissue on the stent circumference was minimal at the outflow aspect.The sewing ring was cut at multiple locations around the valve circumference.The wireform was exposed on commissure 2, and on the side of the valve near commissure 3.Based on the product evaluation findings, the subject device was failing due to calcification leading to tears and insufficiency.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.A manufacturing deficiency was not identified.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.As stated in the ifu, under observed adverse events, "as with all prosthetic heart valves, serious adverse events, sometimes leading to death, may be associated with the use of tissue valves.In addition, adverse events due to individual patient reaction to an implanted device or to physical or chemical changes in the components, particularly those of biological origin, may occur at varying intervals (hours or days) necessitating reoperation and replacement of the prosthetic device." calcification is a structural deterioration of bioprosthetic valves in which structural deterioration is listed in the ifu.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7343528
• MDR Text Key: 102570546
• Report Number: 2015691-2018-00931
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Model Number: 3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR