BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2703461 · Received August 9, 2012

    Report

    Report Number
    2017233-2012-00535
    Event Type
    Injury
    Date Received
    August 9, 2012
    Date of Event
    June 21, 2012
    Report Date
    July 12, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. TWO EXCLUDER DEVICES (PXT AND PXC) WERE SAFELY IMPLANTED. ALTHOUGH THE FINAL ANGIOGRAM SHOWED SLIGHT TYPE 2 ENDOLEAK, THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-WATCH APPROACH. ON (B)(6) 2012, FOLLOW-UP CT REVEALED A RETROGRADE AORTIC DISSECTION FROM THE PROXIMAL NECK OF THE DEVICE. THE PHYSICIAN RECHECKED THE IMAGE OF THE INITIAL PROCEDURE. HE FOUND THAT THERE WAS A RETROGRADE BLOOD FLOW IN THE IMAGE. BUT, THE PHYSICIAN SAID THAT NO ONE IDENTIFIED THE DISSECTION DURING THE PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF DISSECTION WAS THE OVER INFLATION OF THE BALLOON (TOKAI MEDICAL BALLOON).

    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 9990356

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other