BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 10525800 · Received September 11, 2020

    Report

    Report Number
    2017233-2020-01249
    Event Type
    Death
    Date Received
    September 11, 2020
    Date of Event
    November 30, 2010
    Report Date
    September 28, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132610143
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1 UPDATED. H.6. CONCLUSIONS CODE 1 UPDATED. H.6. CONCLUSIONS CODE 2 ADDED. H.6. CONCLUSIONS CODE 2: CODE 22 - ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, ANEURYSM ENLARGEMENT, ANEURYSM RUPTURE AND DEATH. FURTHERMORE, THE IFU INFORMS USERS OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS, AND USERS ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: CATALOG #: PXC181000 / SERIAL #: (B)(4) / UDI #: (B)(4). CATALOG #: PXC201200 / SERIAL #: (B)(4) / UDI #: (B)(4). PATIENT WEIGHT: ASKED BUT UNAVAILABLE. OUTCOMES ATTRIBUTED TO ADVERSE EVENT - DEATH - DATE OF PATIENT DEATH: AS THE DATE OF PATIENT DEATH IS REPORTEDLY UNKNOWN, BUT REPORTED AS AROUND (B)(6), THE DATE OF PATIENT DEATH HAS BEEN ESTIMATED AS (B)(6) 2020. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TYPE II ENDOLEAK WAS DETECTED AT FINAL ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN EARLY (B)(6) 2020 A PROXIMAL TYPE I ENDOLEAK, A DISTAL ENDOLEAK ON BOTH THE RIGHT AND LEFT SIDE, AND ANEURYSM ENLARGEMENT WERE CONFIRMED. A RE-INTERVENTION AND ADDITIONAL STENT GRAFT PLACEMENT ON BOTH THE PROXIMAL AND DISTAL SIDES WAS PLANNED FOR (B)(6) 2020. HOWEVER, ON AN UNKNOWN DATE IN MID (B)(6) 2020 (REPORTED AS AROUND (B)(6)) THE PATIENT EXPIRED DUE TO ANEURYSM RUPTURE. IT WAS REPORTED THAT THE ATTENDING PHYSICIAN WAS UNABLE TO OBTAIN DETAILED INFORMATION REGARDING THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989289 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PXT231414 00733132610143

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death