BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3246628 · Received July 22, 2013

    Report

    Report Number
    2017233-2013-00479
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 17, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GORE TRI-LOBE BALLOON CATHETER THE LOT/SERIAL NUMBER IS UNK. A REVIEW OF THE MFG RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED. FURTHER INFO WAS REQUESTED. ALSO WAS USED TGU404020/ 9944700. THIS DEVICE WAS CAPTURED IN MEDWATCH # 2017233-2013-00478.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH TWO CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS AND A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT A PSEUDO ANEURYSM IN THE ARCH OF THE THORACIC AORTA. IT WAS REPORTED THAT THE PT HAD A PRE-EXISTING ANEURYSM RUPTURE. THE PHYSICIAN ALSO IMPLANTED A CONTRALATERAL LEG COMPONENT FROM THE INNOMINATE ARTERY TO THE AORTA TO MAINTAIN PROFUSION. DURING THE PROCEDURE THERE WAS A PROXIMAL TYPE I ENDOLEAK FROM THE AREA WHERE THE EXCLUDER AND TAG DEVICES CAME TOGETHER. THE PHYSICIAN BALLOONED THE PROXIMAL GORE TAG THORACIC ENDOPROSTHESIS USING THE GORE TRI-LOBE BALLOON CATHETER THREE TIMES TO GAIN VESSEL SEAL. DURING THE THIRD ATTEMPT, THE ASCENDING THORACIC AORTA RUPTURED. THE PHYSICIAN THEN PERFORMED A STERNOTOMY AND FOUND THE ASCENDING THORACIC AORTIC TISSUE TO BE FRIABLE AND ALMOST TRANSLUCENT. THE PT HAD MASSIVE BLEEDING AND EXPIRED. THE PHYSICIAN IS NOT CONTRIBUTING THE CAUSE OF DEATH TO THE GORE DEVICE, BUT TO THE PT BLEEDING OUT DURING THE PROCEDURE. FURTHER INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341422 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9944700

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H