BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3161551 · Received May 5, 2013

    Report

    Report Number
    2953161-2013-00083
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 17, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. FURTHERMORE, ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SIGNIFICANT THROMBUS AND/OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND THE DISTAL ILIAC ARTERY INTERFACE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT OF ACUTE THROMBOSIS OF THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT WITH ISCHEMIC REST PAIN IN THE LOWER LEFT EXTREMITY. THE PHYSICIAN STATED THE THROMBOSIS WAS CAUSED BY THE PATIENT'S DISEASED AND TORTUOUS LEFT ILIAC ARTERY. TWO ADD'L GORE EXCLUDER AAA ENDOPROSTHESES WERE IMPLANTED TO TREAT THE THROMBOSIS, AND A THROMBECTOMY OF THE AORTA AND ILIAC SEGMENT WAS ALSO PERFORMED. IT WAS REPORTED THE IMPLANT OF THE TWO DEVICES RESULTED IN NO OBVIOUS OBSTRUCTIVE LESION IN AORTA AND ILIAC SEGMENTS, AND PATENCY WAS ACHIEVED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196180 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 10574991

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R OMEPRAZOLE| SIMVASTATIN| PERCOCET| NITROGLYCERIN| MARIJUANA| CIALIS| CRESTOR| PLAVIX| NICOTROL INHALER