BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS

    MDR report key: 11766725 · Received May 3, 2021

    Report

    Report Number
    2017233-2021-01947
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    January 20, 2020
    Report Date
    October 18, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. UPDATED. H.6. CONCLUSION CODE 1: 22: ACCORDING TO THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAKS. H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    CHECKED B1 AS ADVERSE EVENT. ADDED PMA NUMBER TO G3/G4: P040043.

    Description of Event or Problem · 0

    ON (B)(6), 2014, A PATIENT UNDERWENT TREATMENT OF A PENETRATING AORTIC ULCER WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6), 2020 AN UNSPECIFIED ENDOLEAK WAS REPORTED. THIS WAS CONFIRMED BY THE PHYSICIAN TO BE A TYPE I DISTAL DISTAL ENDOLEAK CAUSED BY CONTINUAL EXPANSION OF THE COMMON ILIAC ARTERY ANEURYSM. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED WHEREBY THE ENDOLEAK WAS TREATED WITH IMPLANT OF AN ADDITIONAL DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAKS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2014, A PATIENT UNDERWENT TREATMENT OF A PENETRATING AORTIC ULCER WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2020 AN UNSPECIFIED ENDOLEAK WAS REPORTED. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED WHEREBY THE ENDOLEAK WAS TREATED WITH IMPLANT OF AN ADDITIONAL DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662159 CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R