BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2850829 · Received November 21, 2012

    Report

    Report Number
    2017233-2012-00771
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    July 9, 2008
    Report Date
    November 14, 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

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING GORE TAG THORACIC ENDOPROSTHESIS. PRIOR TO THE TAG IMPLANTATION, A RIGHT CAROTID TO LEFT CAROTID ARTERY BYPASS WAS PERFORMED USING A VASCULAR GRAFT. THEN, THE TAG DEVICE WAS DISPLAYED, INTENTIONALLY COVERING THE LEFT COMMON CAROTID ARTERY. AFTER TOUCH-UP BALLOONING, ANGIOGRAPHY REVEALED EVIDENCE OF THROMBOSIS AT THE ANASTOMOSIS SITE OF THE VASCULAR GRAFT USED FOR THE CAROTID TO CAROTID BYPASS. THEREFORE, A THROMBECTOMY WAS PERFORMED. THE PROCEDURE CONCLUDED. POSTOPERATIVELY, THE PT SUSTAINED A CEREBRAL INFARCT. REHABILITATION WAS STARTED AND THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2008. ACCORDING TO THE PHYSICIAN, THE INFARCT WAS CAUSED BY THROMBECTOMY, NOT BY THE TAG DEVICE OR PROCEDURE.

    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 05941688

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R