MAUDE Adverse Event Report: EDWARDS LIFESCIENCESMCCARTHY MYXO ETLOGIX ANNULOPLASTY RING

Model Number 5100

Device Problem Paravalvular leak

Event Date 11/06/2006

Event Type  Injury   Patient Outcome  Required Intervention

Manufacturer Narrative

Device not returned.

Event Description

Notified of event through fda report. In this report, the patient has reported: ¿i had rheumatic fever. I have been treated for mitral valve regurgitation throughout my adult years. I saw a dr who diagnosed myxomatous disease with bileaflet prolapse. He recommended surgery to repair the mitral valve. Two months later, dr performed the surgery. He implanted a ring. Near the end of the procedure, while in the operation room, i suffered ventricular fibrillation and was cardioverted several times. I also suffered damage to my left ventricle. Before my surgery, my ejection fraction was 60% to 65%. Immediately following surgery, my ef was 32%. More recently, my ef was measured at 25%. I had no lv damage before this surgery, and had no significant coronary artery disease. My follow up car has been through my long time cardiologist. I have had v tach since the surgery. In 2007, i received an implanted pacemaker and defibrillator. In the summer of 2008, i received an article about the ring, which suggested that it was not approved by the fda and was experimental. I was not informed before my surgery that the myxo ring was not approved by the fda, or that it was new, experimental, investigational, or anything of that nature. I was not told that the myxo ring was part of a study. I would never have consented to the use of the myxo ring had i been told that the ring was new, untested, experimental, or anything like that. Also dr and the staff never told me that i suffered heart damage during the 2006 surgery, although that fact is well documented in the medical records. Dates of use: 2006-2009. Diagnosis or reason for use: myxomatous mr. ¿.

• Brand Name: MCCARTHY MYXO ETLOGIX ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section F): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• 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; irvine , CA 92614; (949) 250 -2289
• Device Event Key: 1407140
• MDR Report Key: 1344261
• Event Key: 1281890
• Report Number: 2015691-2009-10095
• Device Sequence Number: 1
• Product Code: KRH
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2009

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/17/2009
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 06/30/2009
• Device MODEL Number: 5100
• Device LOT Number: 6F1252
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Distributor Facility Aware Date: 11/06/2006
• Device Age: 3 mo
• Event Location: Hospital
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 02/19/2009
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/24/2006
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes

Is this an Explanted Device?

• Type of Device Usage: Initial