BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2202356 · Received August 4, 2011

    Report

    Report Number
    2017233-2011-00398
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 3, 2011
    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 MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT ENDOVASCULAR REPAIR USING TWO GORE TAG THORACIC ENDOPROSTHESES AND A DEBRANCHING SURGERY USING VASCUTEK GELWEAVE GRAFTS TO TREAT A THORACIC AORTIC ANEURYSM FROM THE ARCH TO THE DESCENDING AORTA. FIRST THE BRACHIOCEPHALIC ARTERY, LEFT COMMON CAROTID ARTERY AND LEFT SUBCLAVIAN ARTERY WERE BYPASSED FROM THE ASCENDING AORTA USING 12 MM GRAFT AND 8 MM GRAFT. AFTER THAT, TWO TAG DEVICES WERE INSERTED FROM THE ASCENDING AORTA AND SUCCESSFULLY DEPLOYED. THE PHYSICIAN ENDED THE PROCEDURE, AS THE FINAL ANGIOGRAM DIDN'T SHOW THE ENDOLEAK. HOWEVER, AFTER THE PT WAS CARRIED TO THE CCU, HE DEVELOPED THE BRAIN INFARCT. THE PHYSICIAN EMERGENTLY ATTEMPTED SEVERAL BALLOON DILATIONS AND ALSO TRIED TO USE THE MERCI CLOT RETRIEVAL CATHETER TO TREAT THE BASILAR ARTERY INFARCTION, BUT IT WAS NOT SUCCESSFUL. AS OF (B)(6), THE PT REMAINS IN A COMA.

    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 WLG426 8861339

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R