MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT; RING, ANNULOPLASTY

Model Number 4625

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

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

There may be cases where a transcatheter intervention is indicated or performed to treat recurrent regurgitation and/or stenosis after failed annuloplasty ring repair.Annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation and/or stenosis occurs as a result of progression of disease and is not related to a device malfunction.The most likely cause is patient factors, including implant duration over 10 years.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.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.

Event Description

It was learned through implant patient registry that a patient with a 32mm mitral ring implanted for 16 years and 11 months underwent a valve-in-ring procedure due to regurgitation.The procedure was performed with a 29mm transcatheter valve.The patient outcome at the end of the procedure as stable.Per additional information, the perceived root cause of the event: structural deficiency of annuloplasty ring.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16440707
• MDR Text Key: 310227267
• Report Number: 2015691-2023-11092
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2023

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: 12/31/2009
• Device Model Number: 4625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2005
• 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: 72 YR
• Patient Sex: Female