BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2210873 · Received August 12, 2011

    Report

    Report Number
    2015691-2011-16037
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SUBJECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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, IT WAS LEARNED THAT THE AORTIC PROSTHESIS WAS EXPLANTED AT IMPLANT DUE TO A PERIVALVULAR LEAK, AND REPLACED WITH A SAM MODEL, LARGER SIZE 25MM PROSTHESIS. OPERATIVE REPORT INDICATES, "THE SUTURES WERE PASSED THROUGH THE SEWING RING OF THE #23 MAGNA EASE PERICARDIAL VALVE. THE VALVE WAS SEATED AND SUTURES TIED. THE VALVE APPEARED TO SEAT WELL...THE PATIENT WAS REWARMED...TEE CONFIRMED EXCELLENT FUNCTIONING AORTIC VALVE; HOWEVER, THERE APPEARED TO BE A SMALL PERIVALVULAR LEAK; HOWEVER, WHEN THE PATIENT'S BLOOD PRESSURE INCREASED, THE PERIVALVULAR LEAK APPEARED TO BE INSIGNIFICANT...THE AORTIC ROOT WAS OPENED THROUGH THE PREVIOUS ARTERIOTOMY. THE PREVIOUSLY PLACED MAGNA VALVE WAS EXAMINED AND APPEARED TO BE INTACT; HOWEVER, IT APPEARED THAT THERE MAY BE A PERIVALVULAR LEAK AT THE LEFT AND RIGHT COMMISSURE. ALL SUTURES WERE EXCISED, [AND A 25 MM VALVE WAS IMPLANTED IN PLACE]...THE PATIENT TOLERATED PROCEDURE WELL, AND WAS TRANSFERRED IN STABLE CONDITION" THE SURGEON INDICATED THAT THE REASON FOR THIS EXPLANT IS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-11B0657

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R