BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 12874420 · Received November 25, 2021

    Report

    Report Number
    3007284313-2021-01682
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    February 2, 2021
    Report Date
    August 5, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A RETROSPECTIVE AND PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN EARLY DATA ON THE USE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-12 MODULE. THE ABOVE INFORMATION WAS OBTAINED FROM THE CSD. THE SAME PATIENT SHOWED A TYPE III ENDOLEAK. THIS EVENT IS BEING REPORTED ON AN GORE EVENT (B)(4).

    Additional Manufacturer Narrative · 0

    G1: CORRECTED MANUFACTURING PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, GRAFT INFECTION RELATED TO AN ABSCESS IN THE RIGHT GROIN WAS IDENTIFIED. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED, TREATED WITH ANTIBIOTICS, PUNCTURE AND DRAINAGE OF THE ABSCESS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773141 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention