BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3951273 · Received July 22, 2014

    Report

    Report Number
    2015691-2014-01657
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO EDWARDS FOR EVALUATION, THEREFORE, THE CLINICAL OBSERVATION CANNOT BE CONFIRMED OR EVALUATED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    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 SUBJECT EDWARDS MITRAL BIOPROSTHETIC VALVE, IMPLANTED APPROXIMATELY SIX (6) YEARS AND THREE (3) MONTHS, WAS EXPLANTED DUE TO DEGENERATIVE STENOSIS AND REGURGITATION. OPERATIVE FINDINGS INDICATE THE PATIENT HAD A CALCIFIED BIOPROSTHESIS IN THE LATERAL POSITION WITH STENOSIS AND INSUFFICIENCY. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS PERICARDIAL VALVE, WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428052 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R COUMADIN