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

Model Number 4450

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: there is evidence of device-related harm or structural deficiency of the ring that could cause or contribute to a serious injury.This is considered a serious injury.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a patient with a 30mm 4450 mitral ring underwent a valve in ring procedure after an implant duration of 16 years, 2 months due to stenosis and regurgitation.The procedure was performed with a 26mm 9750tfx transcatheter valve.The patient was stable post procedure.The perceived root cause was device deterioration.

Manufacturer Narrative

The causes of surgical or percutaneous intervention for failed annuloplasty repairs are well documented in the literature.This is primarily due to progression of native valvular disease or technical failures and is not related to device malfunction.This may present as recurrent regurgitation and/or stenosis.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.Failed annuloplasty repair re-operations are primarily the result of a progression of disease, the patient's baseline hemodynamics, or technical failures and are not evidence of product malfunctions.The most likely cause is patient factors, including the progression of patient's disease and the implant duration over 10 years.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17552708
• MDR Text Key: 321221685
• Report Number: 2015691-2023-15264
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

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: 12/07/2011
• Device Model Number: 4450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Male