BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3820965 · Received May 20, 2014

    Report

    Report Number
    2015691-2014-01188
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTATION OF A TRANSCATHETER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. BIOPROSTHETIC VALVE DYSFUNCTION ENCOMPASSES MULTIPLE FAILURE MODES/MECHANISMS, WHICH MAY OCCUR SINGULARLY OR CONCOMITANTLY. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF THESE FAILURES INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. HOWEVER, WITHOUT RETURN OF DEVICE AND EVALUATION (REMAINS IMPLANTED), THE SPECIFIC MECHANISM LEADING TO THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED. THE PATIENT'S MEDICAL HISTORY IN THIS CASE (RENAL DISEASE ON DIALYSIS, CAD) MAY HAVE PLAYED AN IMPORTANT ROLE CONTRIBUTING TO THIS EVENT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTED 23 MM MAGNA AORTIC BIOPROSTHETIC VALVE WAS DIAGNOSED WITH SEVERE AORTIC STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY THREE (3) YEARS. THE PATIENT INITIALLY UNDERWENT AN UNSUCCESSFUL TRANSCATHETER VALVE IMPLANTATION DUE TO INADEQUATE TRANSFEMORAL ACCESS, THEN UNDERWENT A SUCCESSFUL IMPLANT OF ANOTHER TRANSCATHETER VALVE WITHIN THE STENOTIC VALVE (VALVE IN VALVE), VIA THE TRANSAPICAL APPROACH (TA). REPORT INDICATES THAT THE REASON FOR THE STENOTIC VALVE WAS DUE TO THE PATIENT HAVING BEEN ON DIALYSIS SINCE PRIOR TO HER IMPLANT OF THE SUBJECT MAGNA VALVE. PATIENT MEDICAL HISTORY INCLUDES: CAD S/P CABG, HTN, ESRD, AORTIC ANEURYSM, PAROXYSMAL ATRIAL FIBRILLATION, PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300391 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R