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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MCCARTHY MYXO ETLOGIX ANNULOPLASTY RING

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EDWARDS LIFESCIENCES MCCARTHY MYXO ETLOGIX ANNULOPLASTY RING Back to Search Results
Model Number 5100
Device Problem Paravalvular leak
Event Date 11/06/2006
Event Type  Injury  
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. ¿.

 
Manufacturer Narrative

Device not returned.

 
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Brand NameMCCARTHY MYXO ETLOGIX ANNULOPLASTY RING
Type of DeviceANNULOPLASTY 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 Key1407140
MDR Report Key1344261
Event Key1281890
Report Number2015691-2009-10095
Device Sequence Number1
Product CodeKRH
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 Received03/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/30/2009
Device MODEL Number5100
Device LOT Number6F1252
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Distributor Facility Aware Date11/06/2006
Device Age3 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/19/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/24/2006
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

Patient TREATMENT DATA
Date Received: 03/17/2009 Patient Sequence Number: 1
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