MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM; ANNULOPLASTY RING

Model Number 4600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 04/16/2014

Event Type  Injury  

Event Description

Edwards received information that a prosthetic annuloplasty ring, implanted approximately ten (10) years and two (2) months, was explanted due to regurgitation.The operative report documents annular dilatation of the mitral valve with [native] leaflet prolapse.The ring was removed and the patient's mitral valve was replaced with a bioprosthetic valve.There are no reported adverse events following implant.

Manufacturer Narrative

The causes of re-operation for a failed annuloplasty repairs are well documented in the literature.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.The reported device was not returned to manufacturer; without receipt of the device the reported clinical observation cannot be confirmed and a root cause cannot be assigned.The device history record review was completed and confirms that this device passed all manufacturing and sterilization inspections.Edwards will continue to review and monitor all events.

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; one edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3900075
• MDR Text Key: 4647185
• Report Number: 2015691-2014-01482
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2014

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: 12/01/2008
• Device Model Number: 4600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/27/2014
• Date Device Manufactured: 12/05/2003
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR