BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2083281 · Received May 10, 2011

    Report

    Report Number
    2015691-2011-15499
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    April 11, 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

    (B)(4) = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE FOLLOW-UP, THE SUBJECT DEVICE HAS NOT BEN RETURNED TO EDWARDS FOR EVALUATION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION, OR A MANUFACTURING QUALITY DEFICIENCY.

    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 ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 26 MONTHS DUE TO RECURRENT PROGRESSIVE MITRAL INSUFFICIENCY. THE ANNULOPLASTY RING, ALONG WITH THE PATIENT'S NATIVE VALVE WERE REPLACED WITH AN EDWARDS TISSUE VALVE. OPERATIVE REPORT INDICATES, "VALVULAR ANALYSIS DEMONSTRATED VARIOUS FIBROTIC RETRACTED POSTERIOR LEAFLETS. WE CUT OUT THE RING AND CUT OUT THE ANTERIOR LEAFLET AND SEWED A 27 MM MAGNA EASE VALVE INTO PLACE." THE SURGEON INDICATED THAT THE REASON FO EXPLANT IS NOT DUE A MALFUNCTION OF THE EDWARDS' ANNULOPLASTY RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-08F1245

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R