BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2705872 · Received August 10, 2012

    Report

    Report Number
    2017233-2012-00540
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    July 13, 2012
    Report Date
    July 31, 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

    EVAL CODE - THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. ADD'L DEVICE IMPLANTED AND INVOLVED IN THIS EVENT TGT4015/9231315, TGT4020/10307301.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM AT AORTIC ARCH-DESCENDING AORTA USING GORE TAG THORACIC ENDOPROSTHESIS AND GORE EXCLUDER AAA ENDOPROSTHESIS WITH CHIMNEY TECHNIQUE. PRIOR TO THE PROCEDURE, ON THE SAME DAY, THE BYPASS (AX-AX AND CA-CA) SURGERY WAS PERFORMED TO KEEP THE BLOOD FLOW TO THE BRANCHES, BECAUSE THE TAG DEVICES WERE PLACED FROM THE ASCENDING AORTA. FIRSTLY, ONE TAG DEVICE WAS IMPLANTED DISTALLY. THE LUNDERQUIST EXTRA STIFF WIRE WAS USED. JUST AFTER THAT, AN ANESTHESIOLOGIST NOTICED THAT THE MONITOR SHOWED THE BRAIN WAVES DISAPPEARED. AS THE STATUS RECOVERED SOON, THE PROCEDURE CONTINUED AND ANOTHER 2 TAG DEVICES AND 1 EXCLUDER DEVICE WERE IMPLANTED. ON (B)(6) 2012, IT WAS REPORTED THAT THE PT DIDN'T AWAKE FROM ANESTHESIA AFTER THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PT DEVELOPED A STROKE AND THERE WAS CEREBRAL INFARCT DUE TO THE EMBOLI. THROMBOSIS AT THE THORACIC AORTA WAS OBSERVED BEFORE THE PROCEDURE, BUT THE VOLUME COULD NOT BE CONFIRMED. ANOTHER PHYSICIAN STATED THAT THE LUNDERQUIST WIRE MIGHT BE RELATED TO THE EVENT. DRUG CONTROL WAS USED TO PREVENT THE BRAIN HYPERTENSION.

    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 10297462

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O