BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1964448 · Received January 19, 2011

    Report

    Report Number
    2015691-2011-14697
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    August 5, 2010
    Report Date
    December 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION.

    Description of Event or Problem · 1

    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. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS AND 10 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO RECURRENT MITRAL STENOSIS AND REGURGITATION. ACCORDING TO THE OPERATIVE REPORT, THIS IS A (B)(6) YEAR-OLD MAN WHO, ABOUT 4 YEARS AGO, HAD AN EXCELLENT MITRAL VALVE REPAIR DONE WITH CONFIRMATORY EVIDENCE, IN THE POSTOPERATIVE ECHO, THAT HE HAD A COMPETENT VALVE, NO STENOSIS AND NO SAM. SUBSEQUENTLY, HE DID WELL, UNTIL ABOUT 6 MONTHS AGO, WHEN HE BEGAN TO GET SHORT OF BREATH AND WAS FOUND TO HAVE SEVERE STENOSIS AND REGURGITATION OF HIS REPAIRED VALVE, SUGGESTING SCARIFICATION ON THE LEAFLETS. HIS CORONARY ARTERIOGRAM WAS AGAIN NORMAL. HE REMAINED IN SINUS RHYTHM. ON BYPASS, THE REPAIR WAS FOUND INTACT. THERE WAS EXTENSIVE SCARIFICATION ALONG THE PLACED COSGROVE RING, EXTENDING DOWN INTO THE POSTERIOR LEAFLET, MAKING IT VIRTUALLY A RIGID SHORTENED LEAFLET, PROMOTING THE STENOSIS AND REGURGITATION. THOUGH AN ATTEMPT WAS MADE TO REPAIR THIS, WE FELT THAT THE BEST AND MOST EFFICACIOUS WOULD BE VALVE REPLACEMENT. THE COSGROVE RING WAS EXCISED. THE VALVE WAS REPLACED WITH AN EDWARDS BIOPROSTHESIS. THE VALVE WAS SEATED AND THE PATIENT WAS RETURNED TO THE ICU IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 R-06G0004

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention