BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3221022 · Received July 5, 2013

    Report

    Report Number
    2017233-2013-00437
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2013, THE PATIENT WAS UNDERGOING TREATMENT WITH A COMFORTABLE GORE TAG THORACIC ENDOPROSTHESIS. IT WAS REPORTED THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A NON-GORE DEVICE IN THE ABDOMINAL AORTA. DUE TO THE PREVIOUSLY IMPLANTED ABDOMINAL GRAFT, THE PHYSICIAN REPORTEDLY COULD NOT ADVANCE THE CTAG DEVICE PAST THE ABDOMINAL AORTA INTO THE THORACIC AORTA. THE PHYSICIAN ELECTED TO REMOVE THE DEVICE FROM THE PATIENT. IT WAS REPORTED THAT UPON WITHDRAWAL OF THE UNDEPLOYED CTAG DEVICE, THE DEVICE CAUGHT ON THE NON-GORE GRAFT CAUSING THE COMFORTABLE GORE TAG THORACIC ENDOPROSTHESIS NITINOL WIRE FLARES TO STRETCH AND DISTORT. THE PHYSICIAN THEN REPORTEDLY CONTINUED WITHDRAWAL OF THE DEVICE. HOVER, DURING THIS FINAL WITHDRAWAL, THE SHARP EDGE CREATED BY THE DISTORTED FLARES DISSECTED THE INTERNAL ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN DECIDED TO PERFORM A FEMORAL ARTERY TO FEMORAL ARTERY BYPASS TO REPAIR THE DISSECTED ARTERY. IT WAS REPORTED THE PHYSICIAN DECIDED TO PERFORM A FEMORAL-FEMORAL BYPASS TO REPAIR THE DISSECTED ARTERY. FINAL ANGIOGRAPHY SHOWED THE BYPASS WAS A SUCCESS WITH NO INJURIES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307467 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 11207201

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R