BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3082963 · Received April 24, 2013

    Report

    Report Number
    2017233-2013-00254
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECS. ADD'L DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: TG4015/03611853 AND TG3715/03612058. THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE REOPERATION.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THIS PATIENT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC AORTIC ANEURYSM. THE PATIENT HAD PREVIOUS ABDOMINAL AORTIC SURGERY TO TREAT AN ABDOMINAL AORTIC ANEURYSM (DATE UNK). IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT PRESENTED EMERGENTLY TO EMERGENCY ROOM WITH A RUPTURED THORACIC AORTIC ANEURYSM. THE RUPTURE WAS DISTAL TO THE PREVIOUSLY IMPLANTED TAG GRAFT. TWO ADD'L CONFORMABLE TAG DEVICES WERE IMPLANTED DISTAL TO THE PREVIOUS GRAFTS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176250 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 03618309

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention