BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4123358 · Received September 26, 2014

    Report

    Report Number
    2015691-2014-02259
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO DRAW ANY DEFINITIVE CONCLUSIONS REGARDING THE CLINICAL OBSERVATIONS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. NO INFORMATION WAS PROVIDED INDICATING THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE EXPIRATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A TRANSCATHETER VALVE WAS IMPLANTED INTO THIS SURGICAL VALVE (VALVE-IN-VALVE) AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE (5) YEARS, FIVE (5) MONTHS DUE TO STENOSIS (MEAN GRADIENT = 33MMHG) AND MILD REGURGITATION, SECONDARY TO CALCIFICATION. THE TAVR VALVE WAS SUCCESSFULLY IMPLANTED; HOWEVER, THE PATIENT BECOME HEMODYNAMICALLY UNSTABLE REQUIRING CPR AND RE-CANNULATION. WHILE ON BYPASS, THE PATIENT WAS TRANSFERRED TO THE ICU. COMFORT MEASURES WERE TAKEN AND THE PATIENT EXPIRED ON POD #4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602588 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R