BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2525499 · Received April 3, 2012

    Report

    Report Number
    2017233-2012-00220
    Event Type
    Death
    Date Received
    April 3, 2012
    Date of Event
    July 4, 2008
    Report Date
    March 22, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE GORE TAG THORACIC ENDOPROSTHESIS IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING: GREATER THAN OR EQUAL TO 2 CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM. CARE SHOULD BE TAKEN NOT TO COVER THE ORIGIN OF ANY MAJOR ARTERIAL BRANCHES IN THE VICINITY OF THE TREATMENT AREA. DO NOT CROSS SIGNIFICANT ARTERIAL BRANCHES WHICH DO NOT HAVE COLLATERAL OR PROTECTED PERFUSION TO END ORGANS OR BODY STRUCTURES. VESSEL OCCLUSION MAY OCCUR. ADDITIONALLY, THE IFU STATES: AFTER DEPLOYMENT, USE THE GORE TRI-LOBE BALLOON CATHETER TO SMOOTH AND SEAT THE ENDOPROSTHESIS AGAINST THE AORTIC WALL IN THE DISTAL AND PROXIMAL NECKS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT UNDERWENT A PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A 70MM THORACIC DESCENDING AORTIC ANEURYSM. THERE WAS NO HEALTHY DISTAL NECK TO THE CELIAC ARTERY DUE TO THE SIZE OF THE ANEURYSM. THE DISTAL TAG DEVICE INTENTIONALLY COVERED THE CELIAC ARTERY AND ALSO INTENTIONALLY PARTIALLY COVERED THE SUPERIOR MESENTERIC ARTERY. TOUCH-UP BALLOONING TO THE DISTAL DEVICE WAS NOT PERFORMED AND AN ANGIOGRAM SHOWED A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND TAKE A WAIT AND WATCH APPROACH. ON (B)(6) 2008, THE PATIENT'S ANEURYSM RUPTURED DUE TO THE DISTAL TYPE I ENDOLEAK. DUE TO THE PATIENT HAVING TERMINAL LUNG CANCER, HE WAS NOT ABLE TO BE CONVERTED TO AN OPEN REPAIR TO TREAT THE RUPTURE AND HE EXPIRED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 05817155

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death