BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 2080701 · Received May 6, 2011

    Report

    Report Number
    2015691-2011-15467
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE DISCARDED AND WILL NOT BE RETURNED. (B)(4) - PARTIAL DEHISCENCE. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT DEVICE RETURN AND EVALUATION (DISCARDED), NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THIS REPORT. THE HEALTHCARE PROVIDER STATED THE EXPLANT IS NOT DUE TO A DEVICE MALFUNCTION.

    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. IT WAS REPORTED THAT THE SUBJECT RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 MONTHS AND REPLACED WITH ANOTHER EDWARDS' ANNULOPLASTY RING, DUE TO MITRAL VALVE REGURGITATION, A PARTIAL DEHISCENCE OF THE RING AS WELL AS POSTERIOR LEAFLET PROLAPSE. THE HEALTHCARE PROVIDE INDICATED THAT THE REASON FOR EXPLANTING THE RING WAS PROCEDURE RELATED, AND NOT DUE TO DEVICE MALFUNCTION. NOTE THAT PATIENT ALSO UNDERWENT TRICUSPID VALVE REPAIR DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-09F1249

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R BYSTOLIC 5 MG