BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11083485 · Received December 28, 2020

    Report

    Report Number
    3007284313-2020-01208
    Event Type
    Death
    Date Received
    December 28, 2020
    Date of Event
    November 30, 2020
    Report Date
    September 20, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622542
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED THE PMA/510(K) NUMBER TO G3/G4: P020004.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: RLT281414/ 20576879 UDI (B)(4), PLC181000/ 21577937 UDI (B)(4), AND PLA280300/ 21636920 UDI (B)(4). CODE 213-THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOT/SERIAL NUMBERS MET ALL PRE-RELEASE SPECIFICATIONS. CODE 22-ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE FOLLOWING WARNING AMONG OTHERS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK AND DEATH.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH A TUBE GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RUPTURED ILIAC ANEURYSM. THE PHYSICIAN HAD PLANNED TO INTERVENE AND COIL THE HYPOGASTRIC ARTERY AND THEN IMPLANT GORE® EXCLUDER® AAA ENDOPROSTHESIS TO CONTAIN THE RUPTURED ANEURYSM. THERE WERE MULTIPLE ISSUES WHILE ATTEMPTING TO ADVANCE THE GUIDEWIRES. THE PHYSICIAN THEN ATTEMPTED AN AUI. THE AUI WAS SUCCESSFUL AND THE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. HOWEVER, A PROXIMAL TYPE I ENDOLEAK WAS PRESENT. THE PHYSICIAN WANTED TO TAKE A WAIT AND APPROACH ON ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. LATER THAT DAY ON (B)(6) 2020, THE PATIENT EXPIRED. NO FURTHER INFORMATION IS AVAILABLE ON THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549099 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT281416 00733132622542

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| O