MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 4100

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Mitral Regurgitation (1964)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.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.A definitive root cause cannot be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that this 32mm ring was explanted after an implant duration of 24 days due to ring dehiscence leading to mitral valve regurgitation.The explanted device was replaced with a non-edwards valve.The outcome was noted as resolved.

Manufacturer Narrative

Udi number: (b)(4).The cause of the event remains indeterminable; however, patient factors and progression of underlying valvular disease may have impacted the event.Added codes.Corrected data.Entry error a1.Inadvertently put serial number in lot number field.Added additional device codes that were originally left out.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9689754
• MDR Text Key: 178564582
• Report Number: 2015691-2020-10467
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2024
• Device Model Number: 4100
• Device Lot Number: 6647340
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 99