BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3726173 · Received April 4, 2014

    Report

    Report Number
    2017233-2014-00177
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 3, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXCLUDER DEVICES INCLUDED IN THIS REPORT: RMT281214/9343327, PXC121000/9212400. A REVIEW OF THE MANUFACTURING AND STERILIZATION 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 ENDOPROSTHESIS INFECTION AND SURGICAL CONVERSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS INCLUDE DAPTOMYCIN, ASPIRIN, LINEZOLID, CARVEDILOL, SERTRALINE, NORCO, BUMEX, CEFAZOLIN, DOCUSATE, AND LOVENOX.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES (RMT281214/9343327 AND PXC121000/9212400) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON VARIOUS UNKNOWN DATES, MULTIPLE DIAGNOSTIC EXAMINATIONS (COMPUTED TOMOGRAPHY, GASTRO-INTESTINAL SCOPES, MAGNETIC RESONANCE) REVEALED RECURRENT SEPSIS OF UNKNOWN ORIGIN, AND AN INFECTED STENT GRAFT IN THE INFRARENAL AORTA. ON (B)(6) 2014, THE PATIENT UNDERWENT A PROCEDURE WHEREBY THE EXCLUDER GRAFT SYSTEM WAS EXPLANTED, AND THE THORACIC AND INFRARENAL AORTA WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED GRAFTS WERE DISCARDED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204453 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9343327

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R