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

Model Number 662525MM

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

Patient Problem Mitral Regurgitation (1964)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration.Regurgitation, which develops progressively over time, can be due to a number of issues including patient related factors or structural valve deterioration.Structural valve deterioration (svd) is the most common reason for bioprostheses explants 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.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.The device was not returned for evaluation, as it remained implanted.Therefore, the root cause for the torn mitral leaflet, leaflet flail, severe mr, and degeneration indeterminable.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.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

It was reported that a 25mm mitral valve implanted 5 years, 3 months ago was disabled via a valve-in-valve procedure due to torn mitral leaflet, leaflet flail, severe mr and degeneration.A transcatheter valve was implanted.The outcome was reported to be successful.

• Brand Name: CARPENTIER-EDWARDS BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• 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; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7105237
• MDR Text Key: 94473465
• Report Number: 2015691-2017-04206
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: 662525MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2010
• 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: 80 YR