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

Model Number 3300TFXJ19

Device Problems Calcified (1077); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506); Incomplete Coaptation (2507); Unintended Movement (3026)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Ppm has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.In this case, the patient required intervention to treat the valve.Based on the available information, the root cause for the ppm and stenosis remains indeterminable.However, it is likely that patient related factors and procedural factors contributed to the event.A supplemental report will be submitted upon product evaluation completion.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that this 19mm aortic pericardial valve, implanted approximately seven (7) years and five (5) months, was explanted due to aortic stenosis.This device was originally implanted at different facility for aortic valve replacement to correct aortic stenosis.Shortly after implant, patient-prosthesis mismatch and moderate aortic regurgitation was observed, and follow-ups had been conducted.This device was explanted and replaced with a 19mm sjm mechanical valve with no adverse patient effects reported as a result of the valve replacement.The patient status was reported as ¿under treatment¿.The device was returned for evaluation.

Manufacturer Narrative

H3.Evaluation summary: the x-ray demonstrated wireform intact and heavy calcification on all three leaflets.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 5mm on leaflet 2 on the inflow aspect.Host tissue on the stent circumference was moderate at the inflow aspect and minimal at the outflow aspect.Leaflet 1 had a 5mm tear near commissure 2.Leaflets 2 and 3 had 3mm tears at the mid-section of the free margin.Calcification was evident at the tears.Sewing cloth of sewing ring was cut up around the valve on the inflow aspect.Wireform was exposed on commissures 1 and 2, around commissure 1 on the outflow aspect, and around leaflet 3 on the inflow aspect.H10: additional manufacturer narrative: customer report of stenosis was confirmed through observed calcification.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis calcification is a well-recognized failure mode of bioprosthetic valves.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.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.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 root cause for the calcification, tears, and pannus remains indeterminable.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8746109
• MDR Text Key: 149628503
• Report Number: 2015691-2019-02375
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2015
• Device Model Number: 3300TFXJ19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR