BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 12676918 · Received October 21, 2021

    Report

    Report Number
    2953161-2021-01100
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    November 21, 2017
    Report Date
    November 16, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610327
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVESTIGATION DETERMINED NO PRODUCT PROBLEM OR DEFICIENCY CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT/INCIDENT FOR THE PATIENT; THE INITIAL MEDWATCH AND ANY SUPPLEMENTAL REPORT SUBMITTED UNDER MANUFACTURER REPORT NUMBER 2953161-2021-01100 WAS SUBMITTED IN ERROR, AND IS HEREBY RETRACTED.

    Additional Manufacturer Narrative · 0

    AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED INCLUDE: PXC201200 / (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2017, THE PATIENT UNDERWENT REINTERVENTION AND CONTRALATERAL LEG COMPONENT WAS IMPLANTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568530 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PXT281418 00733132610327

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention