BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5903274 · Received August 25, 2016

    Report

    Report Number
    3007284313-2016-00156
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    July 2, 2016
    Report Date
    September 20, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: RLT261414 - (B)(4). PLC231000 - (B)(4). PXC141200 - (B)(4). HGB161407 - (B)(4). HGB161407 - (B)(4). CEB231210 - (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE IMPLANTED WITHIN THE INITIAL PROCEDURE: RLT261414 - (01)00733132622450(17)180923(21)14306144, PLC231000 - (01)00733132618576(17)190413(21)14971148, PXC141200 - (01)00733132609956(17)180831(21)14254091, HGB161407 - (01)00733132620159(17)180331(21)13819986, HGB161407 - (01)00733132620159(17)180331(21)13784696, CEB231210 - (01)00733132620203(17)190215(21)14779249.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2016 THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2016 THE PATIENT HAD A STROKE. ON (B)(6) 2016 THE PATIENT RECEIVED AN ENDARTERECTOMY OF THE LEFT INTERNAL CAROTID ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555270 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 14306144

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other