BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1914752 · Received December 3, 2010

    Report

    Report Number
    2015691-2010-14485
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED LEAFLET 3 APPEARS TO BE DROPPED RELATIVE TO LEAFLETS 1 AND 2. LEAFLET 3 EXHIBITS A TEAR AT COMMISSURE 3 THAT MEASURES TO APPROXIMATELY 4-5MM. ALONG THE MIDPOINT OF THE FREE MARGIN OF LEAFLET 3, A TEAR IS DETECTED THAT MEASURES TO APPROXIMATELY 5-6MM INTO THE CUSP AREA. CALCIFICATION IS DETECTED IN THE REGION OF THE DESCRIBED TWO TEARS. AT COMMISSURE 1, LEAFLET 3 SWOLLEN AND DELAMINATED TISSUE IS OBSERVED. CALCIFICATION IS HEAVY IN THE CUSP AREA OF LEAFLETS 1 AND 3, AND MODERATE IN THE CUSP AREA OF LEAFLET 2. THE FREE MARGIN OF LEAFLET 3 EXHIBIT HEAVY CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. HOST TISSUE IS MODERATE AT THE INFLOW ASPECT. IT ENCROACHED ONTO LEAFLET 1 AT THE INFLOW AT THE GREATEST DISTANCE OF APPROXIMATELY 7MM, AND ONTO LEAFLETS 2 AND 3 BY APPROXIMATELY 3MM. THE X-RAY DEMONSTRATES CALCIFICATION. METHOD: X-RAY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES. CALCIFICATION WAS CONFIRMED AS THE PRIMARY MODE OF FAILURE FOR THIS DEVICE. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED AN EXPLANT OF A DEVICE AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS, SIX MONTHS (104.27 MONTHS) DUE TO A TEAR ON ONE OF THE LEAFLETS. HE ALSO REPORTED THAT THE "PATIENT WAS SYMPTOMATIC" AND WILL BE SENDING THE DEVICE BACK FOR EVALUATION.

    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 1L1705

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R