MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the explanted device was received at edwards lifesciences and an evaluation of the product is currently pending.A supplemental report will be submitted upon completion.

Event Description

Edwards received information that this 23mm bioprosthetic aortic heart valve was explanted after ten (10) years, eight (8) months due to regurgitation, secondary to leaflet tears.A 23mm pericardial bioprosthesis was used in replacement and the patient was noted in stable condition, post-operatively.

Manufacturer Narrative

Device evaluated by manufacturer: during visual examination, leaflet 1 had a 6mm tear along commissure 1, and a 4mm tear along commissure 2 followed by a 1.5mm tear near commissure 2.Leaflet 2 had a 9mm tear along commissure 2, and a 3.5mm tear near commissure 3.Leaflet 3 had a 7mm tear along commissure 3.Leaflets were observed to be thickened and swollen near the tears.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 1 at the inflow aspect.Host tissue on the stent circumference was moderate at the inflow and minimal outflow aspect.The sewing ring had been cut around the valve circumference.The wireform was exposed in commissures 2 and 3.X-ray demonstrated moderate calcification on leaflet 2, commissure 3 bent, and wireform intact.Additional manufacturer narrative: based on product evaluation findings, the clinical observation of leaflet tears leading to regurgitation was confirmed.Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.There can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Host tissue/pannus growth likely contributed to this explant.Host tissue is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue ingrowth.It is not currently possible to predict the occurrence and severity for any given patient with a bioprosthetic heart valve.A certain degree of host tissue growth is expected.However, abnormal or severe pannus growth can eventually affect the function of the valve.According to literature, pannus typically occurs between 12 months to 5 years.Since the mechanism of host tissue growth in bioprosthetic heart valves is still not fully understood, the root cause for the host tissue growth for this particular valve cannot be determined at this time.Calcific degeneration is a common cause of bioprosthetic heart valve failures which likely, to a lesser degree, contributed to this explant.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, immune status, and other co-morbidities), 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 valve due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the cause 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.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.

Manufacturer Narrative

Corrected data: through further investigation, it was learned the subject device is not commercially sold in the u.S.But similar to a device sold or marketed in the u.S.The subject device is similar to model 2800 pma p860057/s001.

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms: t&d 2nd floor, office t223; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5973789
• MDR Text Key: 55484907
• Report Number: 2015691-2016-02841
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR