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

Model Number 280023MM

Device Problem Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Congestive Heart Failure (1783)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: there was no allegation of a device malfunction which could be related to a manufacturing non-conformance; therefore, the device history record was not reviewed.The device was not returned to edwards for evaluation.The clinical observation was unable to be 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.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.A manufacturing related issue 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.

Event Description

Edwards was notified that an edwards 23mm aortic valve with an implant duration of 17 years was explanted due to a torn leaflet with severe aortic insufficiency and stenosis.The patient underwent re-do aortic vale replacement with a 25mm edwards valve.The patient recently had several admissions for acute on chronic diastolic and systolic heart failure.Most recently, he was admitted in acute renal failure.He was undergoing workup for tavr; however, given his relatively small bioprosthetic valve size, it was thought he would benefit from surgical aortic valve replacement.Intraoperatively, there was an area during the aortotomy of the pulmonary artery that was firmly adhered to a pledget.This necessitated a cut into the pulmonary artery to fully expose the aortic valve.An aortoplasty was also completed.Given the poor left ventricular function on the preoperative tee, it was felt that the excess clamp time to replace the ascending aorta would have been too dangerous.The cross clamp was released, the heart de-aired, and after the patient was started on dobutamine and epinephrine, the left ventricular function remained quite poor.A intra-aortic balloon pump was placed.The patient was then weaned from bypass with the aid of moderate doses of inotropes.The patient was taken in critical condition to the cvicu.

Manufacturer Narrative

Evaluation summary: the report of torn leaflet was confirmed.Report of insufficiency was visually confirmed due to leaflet tears.Report of stenosis could not be confirmed due to condition of the returned valve.X-ray demonstrated heavy calcification on leaflets 1 and 2 and minimal calcification on leaflet 3.Host tissue on the stent circumference was heavy at the inflow and outflow aspect.Calcification was evident near the tears.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.Host tissue/pannus growth contributed to a lesser degree to this long-term 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.The valve degeneration observed in this case was most likely due to a progression of this patient¿s underlying valvular disease pathology combined with the patient¿s other underlying risk factors.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6107038
• MDR Text Key: 60073482
• Report Number: 2015691-2016-03389
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2003
• Device Model Number: 280023MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/1999
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 53