MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; ANNULOPLASTY RING

Device Problems Structural Problem (2506); Insufficient Information (3190)

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

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

There may be cases where a transcatheter valve is placed through a previously placed annuloplasty ring for recurrent regurgitation and/or stenosis.Annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation and/or stenosis occurs as a result of progression of disease and is not related to a device malfunction.In this case, it was reported that the mitral ring was alleged to be failing, the device was not returned for evaluation, as it remained implanted.In this case, minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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 an unknown model mitral ring was disabled via a valve-in-ring procedure after unknown implant duration due to severe regurgitation.The mitral ring was alleged to be "failing".No additional details were provided.

Manufacturer Narrative

Based on the available information, the root cause of the event was likely due to patient related factors and the progression of the patient's underlying valvular disease pathology.

Event Description

Edwards received additional information through follow up with the healthcare provider.It was reported that an unknown model 30mm mitral ring was disabled via a valve-in-ring procedure after implant duration of approximately 10 years due to severe regurgitation.The mitral ring was alleged to be "failing".The patient had severe mitral regurgitation after deployment of the 1st 26 mm transcatheter valve, across the mitral ring, this valve was too atrial, and the native leaflets were prolapsing through the valve, and there was regurgitation.Therefore, a 2nd valve was placed, this time further into the ventricle, and now there was no paravalvular mitral regurgitation.The patient will be returned to the coronary intensive care unit in stable condition.

Manufacturer Narrative

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

• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7778530
• MDR Text Key: 116955562
• Report Number: 2015691-2018-03340
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• 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: 07/20/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/15/2018; 07/23/2020
• Supplement Dates FDA Received: 09/05/2018; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR