BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4097250 · Received September 17, 2014

    Report

    Report Number
    2017233-2014-00481
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    September 4, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER COMPONENTS INCLUDED IN THIS REPORT: PXC201000/06410365, AND PXC201000/6961277. A REVIEW OF THE MANUFACTURING PAPERWORK FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM RUPTURE AND SURGICAL CONVERSION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES (RMT281414/7859546, PXC201000/06410365, AND PXC201000/6961277) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE IN (B)(6) 2014, COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) REPORTEDLY SHOWED THE STENT GRAFT SYSTEM WAS INTACT, WITH GOOD PROXIMAL AND DISTAL SEAL AND NO EVIDENCE OF ENDOLEAK. NO INFECTION WAS DETECTED, AND THE ANEURYSM HAD REPORTEDLY DISAPPEARED. ON (B)(6) 2014, CTA REVEALED A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN CITED TREATMENT FAILURE, WITH NO OTHER INDICATION AS TO THE POTENTIAL CAUSE OF THE RUPTURE. ON THE SAME DAY, THE PATIENT UNDERWENT AN OPEN PROCEDURE, WHEREBY THE EXISTING STENT GRAFT SYSTEM WAS EXPLANTED AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED EXCLUDER DEVICES WERE NOT AVAILABLE TO BE SENT BACK TO GORE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576531 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7859546

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R