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

Model Number 3000

Device Problems Degraded (1153); Gradient Increase (1270); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Stenosis (2263)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Stenosis, 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.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.Stenosis is most commonly related to patient factors, and is not usually an indication of a device malfunction.The device was not returned for evaluation, as it remains implanted.The root cause of this event cannot be conclusively determined.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 23mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 7 years, 8 months due to stenosis.A 23mm transcatheter valve was implanted.As reported, the md did not allege any early failure of the surgical valve.

Manufacturer Narrative

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

Manufacturer Narrative

H10: additional manufacturer narrative updated b5, b7, f10, and h6 per new information received.

Event Description

It was reported that a 23mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 7 years, 8 months due to degeneration and severe stenosis.A 23mm transcatheter valve was implanted.Patient was discharged on pod #1.As reported, the md did not allege any early failure of the surgical valve.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10304662
• MDR Text Key: 200027948
• Report Number: 2015691-2020-12614
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2015
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• 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: 67 YR