MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 5200M

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

Patient Problem Mitral Regurgitation (1964)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

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.In this case, the root cause of this event cannot be conclusively determined with the available information.The subject device was not returned for evaluation.There is no information suggesting there was any malfunction or deficiency of the edwards ring.However, this event was likely due to patient and/or procedural related factors.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues 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.Please reference mfr report #2015691-2020-13170 for the report submitted on the patient's aortic valve.

Event Description

Edwards implant patient registry received information a 21mm 3300tfx and a 26mm 5200 mitral annuloplasty ring were explanted after an implant duration of four (4) years due to symptomatic severe aortic stenosis, patient prosthesis mismatch, significant early degeneration of aortic valve, and dehisced mitral ring with significant mitral regurgitation.Patient presented with congestive heart failure and endocarditis (serratia marcescens).Patient had pacemaker lead infection which required replacement.The 21mm valve was replaced with a 23mm 3300tfx aortic pericardial valve.There was no evidence of vegetation or infection of the aortic valve that was indwelling.This may been related to a relatively small sized valve.The explanted 26mm 5200 mitral ring was replaced with a 29mm 7300tfx mitral valve.There was no evidence of infection of the mitral valve leaflets.Mitral valve did have rheumatic appearing changes and fibrosis on both of the valve leaflets as well as the subvalvular apparatus.In addition to this, there was a mitral valve ring, which was small and also dehisced through approximately 180 degrees of the posterior portion mitral valve ring.The patient was transported intubated in satisfactory condition to the icu.Patient was discharged home in stable condition on post-operative day 14.Per implantation data cards, the explants were not due to deficiency of the devices.

Manufacturer Narrative

H10.Additional manufacturer narrative: added h6 result code and conclusion codes.The cause of the event was due to patient factors/condition.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10462525
• MDR Text Key: 204873808
• Report Number: 2015691-2020-13324
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 5200M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR