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

Model Number 4450M32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

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 32mm 4450m annuloplasty ring, implanted in the mitral position, underwent a valve-in-ring procedure after an implant duration of six (6) years, six (6) months due to mitral regurgitation.The root cause of this identified to be distortion of the annuloplasty ring.The procedure was performed with a 29mm 9600tfx transcatheter valve.The patient expired due to pulmonary issues.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Although the product was not returned and there is an allegation, regurgitation after an implant duration of 6 years is most commonly related to patient factors, and is not a result of a manufacturing non-conformance.Additionally, there is no evidence of product failure with regard to design, reliability, or use error.Thus, an engineering evaluation will not be performed.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.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 progression of patient's disease.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17280182
• MDR Text Key: 318648365
• Report Number: 2015691-2023-14437
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

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 Expiration Date: 05/09/2021
• Device Model Number: 4450M32
• Device Catalogue Number: 4450M32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/31/2023
• Date Device Manufactured: 05/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male