BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1180052 · Received September 26, 2008

    Report

    Report Number
    2017233-2008-00669
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 26, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: VASCULAR TRAUMA (E.G., VESSEL DISSECTION). PLEASE NOTE: ADDITIONAL DEVICES IMPLANTED/EXPLANTED: PXC121000 AND PXA230300.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESIS. THE INTRA-OPERATIVE ANGIO INDICATED A PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN THEN RE-BALLOONED WITH A CODA BALLOON. THE NEXT ANGIO SHOWED THE PROXIMAL AORTIC DISSECTION IN THE SAME LOCATION AS THE TYPE 1 ENDOLEAK. THE PHYSICIAN FIRST ADDED A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC CUFF WHICH DID NOT REPAIR THE PROXIMAL AORTIC DISSECTION. THE PHYSICIAN THEN PERFORMED AN OPEN PROCEDURE TO REPAIR THE ANEURYSM AND THE DISSECTION. THE GORE EXCLUDER AAA ENDOPROSTHESES WERE ALL EXPLANTED AND DISCARDED AT THE FACILITY. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES,INC WLG325 05716282

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention