BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2618941 · Received June 11, 2012

    Report

    Report Number
    2017233-2012-00406
    Event Type
    Injury
    Date Received
    June 11, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    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

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

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC DISSECTION USING GORE TAG THORACIC ENDOPROSTHESIS. THE DISSECTION WAS FROM THE LEFT SUBCLAVIAN ARTERY TO THE DESCENDING AORTA. THE PHYSICIAN'S PLAN WAS TO USE 2 TAG DEVICES AND A PXA DEVICE WITH CHIMNEY TECHNIQUE TO KEEP THE FLOW TO THE LEFT COMMON CAROTID ARTERY. AN AORTIC EXTENDER AND A TAG DEVICE WERE IMPLANTED FIRSTLY. WHEN THE PHYSICIAN INSERTED ANOTHER TAG DEVICE BEFORE REACHING THE TARGET POSITION, HE FELT A RESISTANCE TO ADVANCE IT. THE PHYSICIAN STOPPED AND TRIED TO PULL THE DELIVERY CATHETER BACK INTO THE SHEATH. HOWEVER, THE DISTAL END OF THE DELIVERY CATHETER GOT STUCK ON THE EDGE OF SHEATH. THE ANGIOGRAM SHOWED THAT THE DISTAL END OF THE DEVICE WAS PARTIALLY DEPLOYING. THE PHYSICIAN CUT DOWN AT THE RIGHT FEMORAL ARTERY (OR RIGHT EIA) AND CUT THE CATHETER OFF AND REMOVED IT. THE CUT-DOWN-ACCESS VESSEL WAS REPAIRED USING A VASCULAR GRAFT. ANOTHER PXC WAS IMPLANTED AT THE RIGHT EIA (UPPER TO THE VASCULAR GRAFT) TO SEAL A POSSIBLE EIA DISSECTION. AT THAT TIME, AN ANGIOGRAM SHOWED THAT THE AORTIC DISSECTION WAS MAINLY TREATED BY THE IMPLANTED TAG AND PXA DEVICE. IT WAS REPORTED THAT THERE WAS LESS THAN 1L OF BLOOD LOSS. THE PATIENT TOLERATED THE PROCEDURE AND WAS FINE.

    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 9421515

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R