BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2122931 · Received June 3, 2011

    Report

    Report Number
    2953161-2011-00128
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 1, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS HAS BEEN CONDUCTED. THE MFG RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. AFTER BALLOONING THE DISTAL PORTION OF THE TRUNK WITH A 32 MM CODA BALLOON, A FOCAL DISSECTION AND PERFORATION OF THE LEFT ILIAC ARTERY WAS IDENTIFIED WITH EXTRAVASATION OF CONTRAST AT THE DISTAL END OF THE TRUNK. THERE WAS A 5 MMHG DROP IN THE SYSTOLIC BLOOD PRESSURE, AND NO INCREASE IN HEART RATE. A CODA BALLOON WAS THEN SLOWLY INFLATED AT THE DISSECTION SITE, AND NO FURTHER EXTRAVASATION OF CONTRAST WAS SEEN. THE PROCEDURE CONCLUDED, AND THE PT LEFT THE OPERATING ROOM IN STABLE CONDITION. APPROX 1.5 HOURS LATER, THE PT'S SYSTOLIC BLOOD PRESSURE DROPPED TO 70 MMHG, AND SHE WAS GIVEN 2 OR 3 UNITS OF BLOOD, ALTHOUGH NO EXTRAVASATION OF CONTRAST WAS OBSERVED AT THE DISSECTION SITE, WHICH WAS ~6 MM PROXIMAL TO THE EXTERNAL ILIAC ARTERY. A VASCULAR PLUG WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY, AND THE TRUNK WAS EXTENDED DISTALLY WITH A CONTRALATERAL LEG. THE PT HAS HAD NOT FURTHER COMPLICATIONS, AND WAS DISCHARGED IN GOOD CONDITION. ACCORDING TO THE FSA, THE ILIAC ARTERY DISSECTION/PERFORATION WAS DUE TO EXCESSIVE BALLOONING AT THE DISTAL END OF THE TRUNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG425 8376002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R CARVEDILOL| ANASTROZOLE| PLAVIX| BILATERAL SHOULDER REPLACEMENT