BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2222311 · Received August 24, 2011

    Report

    Report Number
    2015691-2011-16100
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AND WILL NOT BE RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. BIOPROSTHETIC VALVE STENOSIS COULD BE DUE TO MANY FACTORS (CALCIFICATION, PANNUS GROWTH, ETC). WITHOUT DEVICE RETURN AND EVALUATION, NO ADDITIONAL INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THE REPORTED STENOSIS AND THIS EXPLANT. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR 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 AORTIC BIOPROSTHESIS WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 90 MONTHS, AND REPLACED WITH ANOTHER PERICARDIAL VALVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO STENOSIS. OPERATIVE REPORT INDICATES THE VALVE WAS VERY STIFF. PATIENT ALSO UNDERWENT REPAIR OF AN ANEURYSM OF THE ASCENDING THORACIC AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 3K1682

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R