BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING

    MDR report key: 2071254 · Received April 27, 2011

    Report

    Report Number
    2015691-2011-15350
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED, AND NOT RETURNED FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS PROCEDURE RELATED, AND NOT DUE TO THE EDWARDS' DEVICE MALFUNCTION. THE INVESTIGATION REVEALS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    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 LEARNED THAT THE EDWARDS' RING WAS EXPLANTED AFTER IMPLANT DURATION OF APPROXIMATELY 4 MONTHS, AND A VALVE REPLACEMENT WAS PERFORMED. THROUGH ADDITIONAL FOLLOW-UP, THE SURGEON INDICATED THAT THE EXPLANT IS PROCEDURE RELATED, AND IS NOT DUE TO A MALFUNCTION OF THE EDWARDS' DEVICE. THE OPERATIVE REPORT INDICATES, " THE INSPECTION OF THE VALVE WHEN IT WAS EXPOSED SHOWED DEHISCENCE OF THE A3 SEGMENT OF THE PHYSIO RING. THERE WERE NO RUPTURED CHORDS ALTHOUGH THE PREOPERATIVE ECHOCARDIOGRAM DID SHOW A POSTERIORLY DIRECTED JET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 6C0554

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R