BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2944004 · Received February 5, 2013

    Report

    Report Number
    2015691-2013-19195
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENOSIS OF AN IMPLANTED VALVE, LIKE REGURGITATION, MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION. THE EXPLANTED DEVICE HAS NOT YET BEEN RECEIVED BY EDWARDS FOR EVALUATION; THEREFORE, THE REPORTED LEAFLET CALCIFICATION AND HOST TISSUE GROWTH CANNOT BE CONFIRMED OR EVALUATED. 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. IT IS LIKELY THAT THE PATIENT'S AGE, DISEASE STAGE, AND MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SALES THAT AN EDWARDS MITRAL BIOPROSTHETIC VALVE WAS EXPLANTED DUE TO MITRAL STENOSIS AFTER AN IMPLANT DURATION OF 32 MONTHS. INITIAL REPORT INDICATES CALCIFIED AND POORLY MOBILE LEAFLETS, PROSTHETIC MS/MR, SEVERE IN (B)(6). THE MITRAL DEVICE WAS REPLACED WITH A MECHANICAL VALVE. THE OPERATIVE REPORT DETAILS INDICATE: " THE MITRAL VALVE BIOPROSTHESIS WAS WE LL SEATED. THERE WAS SOME PANNUS BUT NOT A LOT. THERE WAS CALCIFICATION OF 1 OF THE LEAFLETS AND THE OTHER 2 LEAFLETS WERE STIFF AND NON COMPLIANT. THERE WERE NO OBVIOUS VEGETATIONS OR PERFORATIONS. HOWEVER, THE VALVE STITCHES TILEMSELVES WERE FAIRLY LOOSE. THE VALVE ITSELF WAS WELL SEATED .WITH PANNUS INGROWTH. AT THE END OF THE OPERATION, THE TRANSESOPHAGEAL ECHO SHOWED THE MECHANICAL MITRAL VALVE WAS WELL SEATED WITH GOOD MOVEMENT OF BOTH LEAFLETS OF THE MECHANICAL VALVE AND NO PARAVALVULAR LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47432 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7000TFX R-08L2440

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R XENOPENEX| ALBUTEROL| LYRICA 150 MG| HEPARIN DRIP| PERCOCET| LASIX 40 MG| AMBIEN 10 MG| XANAX 0.25 MG| TOPROL 50 MG