BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 5131284 · Received October 7, 2015

    Report

    Report Number
    2015691-2015-02555
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 8, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE NOT EVALUATED THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS DUE DENIAL FROM THE MEDICAL FACILITY DUE TO THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA). WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT, OR CONFIRM THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC MITRAL HEART VALVE WAS EXPLANTED AFTER FOUR (4) YEARS, ELEVEN (11) MONTHS DUE TO MITRAL STENOSIS AND MITRAL INSUFFICIENCY. UPON EXAMINATION, THE SEWING RING WAS NOT COMPLETELY INCORPORATED, WHICH MAY REPRESENT ENDOCARDITIS GIVEN THE PATIENT'S EARLY HISTORY OF VALVE DEGENERATION AS WELL. DUE TO THE PATIENT'S HISTORY OF ALCOHOL ABUSE, IT WAS FELT NOT TO BE SAFE TO IMPLANT A MECHANICAL PROSTHESIS. THEREFORE, A 25MM PERICARDIAL BIOPROSTHESIS WAS IMPLANTED IN REPLACEMENT. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS LATER DISCHARGED ON POD #4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661822 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R