BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1815122 · Received August 23, 2010

    Report

    Report Number
    2017233-2010-00376
    Event Type
    Death
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    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

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED AND RELATED TO THIS EVENT: TGT3115/7905056, TGT3110/7448772, TGT3420/7999804, TGT3415/8049216.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. AT THE DISTAL END OF THE AORTIC NECK, A PALMAZ STENT WAS IMPLANTED TO REINFORCE THE SEAL. NO ENDOLEAK OR COMPLICATIONS WERE REPORTED AT THIS TIME. ONE HOUR LATER, THE PATIENT WAS REPORTED TO BE IN CARDIAC ARREST. AN ARTIFICIAL HEART-LUNG APPARATUS WAS USED AND A BLOOD TRANSFUSION WAS PERFORMED. AN ANGIOGRAM SHOWED A DISSECTION AROUND THE LEFT SUBCLAVIAN ARTERY. TWO ADDITIONAL TAG DEVICES WERE IMPLANTED AT THE PROXIMAL END OF THE INITIALLY PLACED TAG DEVICES TO TREAT THE DISSECTION. THE ADDITIONAL DEVICES WERE PLACED JUST BELOW THE LEFT COMMON CAROTID ARTERY. NO ENDOLEAK WAS NOTED ON THE FINAL ANGIOGRAM. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN UNSTABLE CONDITION AND EXPIRED LATER THAT DAY. THE PHYSICIAN FELT THE CAUSE OF DEATH WAS HEMORRHAGIC DEATH DUE TO THE AORTIC RUPTURE. THE PHYSICIAN STATED HE FELT THE RUPTURE WAS ATTRIBUTED TO THE DISSECTION AROUND THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN ALSO STATED THAT THE DISSECTION MIGHT BE DUE TO THE BALLOONING OF THE PROXIMAL AORTIC NECK. NO AUTOPSY WAS PERFORMED TO CONFIRM THE CAUSE OF THE DISSECTION.

    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 WLG326 7909018

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death ROCK BALLOON OCCLUSION CATHETER MADE BY A| A LARGE PALMAZ STENT| DOMESTIC MANUFACTURER.| LUNDQUIST GUIDEWIRE