BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2111999 · Received June 2, 2011

    Report

    Report Number
    2015691-2011-15668
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 17, 2011
    Report Date
    May 4, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MULTIPLE ATTEMPTS, NO ADDITIONAL INFORMATION WAS PROVIDED AND DEVICE HAS NOT BEEN RETURNED BY THE HEALTHCARE PROVIDER. BIOPROSTHETIC HEART VALVE STENOSIS AND REGURGITATION CAN BE DUE TO MANY FACTORS (E.G. CALCIFICATION, PANNUS GROWTH, FIBROSIS, ETC.). WITHOUT DEVICE RETURN AND ADDITIONAL INFORMATION, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EXPLANT.

    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' VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 120 MONTHS. PER FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO STENOSIS AND REGURGITATION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY.

    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 0L1632

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R