MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 4600

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Mitral Regurgitation (1964); Regurgitation, Valvular (2335)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The causes of re-operation for a failed annuloplasty repairs are well documented in the literature.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.In this case, there was allegation of device malfunction.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.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported via the implant patient registry that a 34mm mitral ring, implanted for two (2) years and 11 months, was explanted due to severe recurrent regurgitation.The explanted device was replaced with a 25mm bioprosthetic valve.The valve was properly positioned and there was free movement and coaptation of the bioprosthetic valve leaflets.The patient also received a 23mm 8300ab aortic valve during the procedure.Intraoperative tee showed properly positioned and functioning aortic and mitral valve bioprostheses without any paravalvular or central leaks.The patient tolerated the procedure well.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-(b)(4).

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8962353
• MDR Text Key: 161056973
• Report Number: 2015691-2019-03300
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2021
• Device Model Number: 4600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR