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

Model Number 5200

Device Problem Structural Problem (2506)

Patient Problems Failure of Implant (1924); Mitral Valve Stenosis (1965); Thrombosis (2100)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded by hospital staff.The clinical observation was unable to be confirmed.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.A definitive root cause could not be determined.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported via the implant patient registry that a ring model 5200m28 implanted in the mitral position was explanted after an implant duration of approx 15 days due to mitral stenosis and thrombosis in a (b)(6) patient.The patient received a mitral and a tricuspid edwards crosgrove 26 mm ring due to severe mitral regurgitation, moderately severe tricuspid regurgitation and atrial fibrillation.The patient requested a mechanical valve but, due to the past history of alcohol abuse and elevated liver enzymes was not possible to tolerate the anticoagulant therapy.At pod 15 the mitral ring was explanted due to severe mitral stenosis and a 7300tfx31mm edwards mitral valve was put in replacement.As reported, a clot found in front of the mitral valve ring was removed.Another clot found on the tricuspid ring was also removed and the valve was debrided, this valve was tested and appeared to be competent.The tee showed excellent replacement with no mitral regurgitation and no pvl.The tricuspid regurgitation was only mild.The patient was noted to be successfully recovered.Patient history: rheumatic mitral stenosis and severe regurgitation, moderate tricuspid regurgitation, alcohol abuse, elevated liver enzymes, congestive heart failure, bilateral pitting edema in his legs.

Manufacturer Narrative

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.

Manufacturer Narrative

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

• 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: 7960720
• MDR Text Key: 123578405
• Report Number: 2015691-2018-04177
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: 5200
• 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: 41 YR