BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA EVG BIFURCATED BODY

    MDR report key: 2033923 · Received March 18, 2011

    Report

    Report Number
    3002808486-2011-00010
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 17, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SENT TO COOK INC FOR EVALUATION. SUPPLIER NOTES WILL BE SENT TO WILLIAM COOK (B)(4). UNKNOWN AS INFORMATION WAS NOT PROVIDED BY REPORTER. (B)(4): DEVICE FORWARDED TO COOK INC ON (B)(4), 2011. AS OF THIS DATE COOK INC HAS NOT YET RECEIVED THE DEVICE. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    AS PER E-MAIL FROM SALES REPRESENTATIVE: "THE GRAFT WAS IMPLANTED IN 2005: TYPE 2 ENDOLEAK FROM THE MI FROM DAY 0 AFTER IMPLANTATION. BUT YOU DID NOT SEE MORE CONTRAST IN THE ANEURYSMAL SACK THAN BEFORE. DIAMETER OF THE ANEURYSM WAS GROWING BUT REAL SLOW; ABOUT 8MM IN 5 YEARS. (B)(6), 2011 THE PATIENT CAME IN WITH A CONTAINED RUPTURE. (B)(6), 2011 EXPLANTATION OF THE GRAFT TOOK PLACE. THE PHYSICIANS MEASURED THE PRESSURE IN THE SACK AND IT WAS THE SAME AS THE PATIENT'S PRESSURE. SO IT SEEMED AS THERE WAS NO ENDOGRAFT. (B)(6), 2011: IT WAS CONFIRMED THAT ADVERSE EFFECT ON PATIENT WAS: ACUTE ABDOMINAL PAIN (PRIOR TO DEVICE EXPLANTATION). A VASCULAR CLAMP WAS PUT ABOVE THE TRUNCUS, THE PHYSICIANS OPENED THE ANEURYSM AND THERE YOU SAW THE GRAFT. EVERYTHING LOOKED FINE. WHEN THE PHYSICIANS OPENED THE CLAMP, BLOOD WAS COMING OUT REAL FAST AT ONE OF THE STITCHES. THE PHYSICIANS ALSO EXPLANTED A ZENITH ENDOGRAFT. SECTION WHICH REMAINED IN THE BODY: SUPRA RENAL STENT STAYED IN PLACE. FURTHER INFORMATION RECEIVED ON (B)(6), 2011: THE EXACT PARTS NUMBERS OF THE INVOLVED DEVICES: TFFB WITH POSSIBLE ENDOLEAK TYPE III. PARTS OF DEVICE INVOLVED: ONLY MAIN BODY HAD PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA EVG BIFURCATED BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E1714809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening