BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2987360 · Received February 19, 2013

    Report

    Report Number
    2953161-2013-00027
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS. CONCLUSIONS - PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM FROM THE TRANSVERSE ARCH TO THE DESCENDING AORTA. THE PHYSICIAN EMPLOYED A CHIMNEY TECHNIQUE USING TWO GORE CONTRALATERAL LEG COMPONENTS. DURING THE PROCEDURE, A TAG DEVICE ((B)(4)) WAS DEPLOYED DISTALLY AS PLANNED. NEXT, A TAG DELIVERY CATHETER ((B)(4)) WAS ADVANCED INTO THE ASCENDING AORTA AND POSITIONED, BUT NOT YET DEPLOYED. THE PHYSICIAN ACCESSED THE LEFT AND RIGHT COMMON CAROTID ARTERIES (CCA'S), AND ADVANCED SUPER-STIFF DOWN BOTH ARTERIES, AND BESIDE THE TAG DELIVERY CATHETER. THE PHYSICIAN PLANNED A "DOUBLE CHIMNEY", WHERE A CONTRALATERAL LEG COMPONENT (PXC) WOULD BE IMPLANTED AT THE BOTH THE INNOMINATE-AORTA AND LCCA-AORTA JUNCTIONS. IT WAS REPORTED THAT WHEN PHYSICIAN ADVANCED THE GORE DRYSEAL SHEATH ((B)(4)) ALONG THE GUIDE WIRE, THE PHYSICIAN INADVERTENTLY WITHDREW THE GUIDE WIRE. IT WAS THE HALF WAY TO THE TARGET POSITION OF THE SHEATH. IT WAS REPORTED THE PHYSICIAN ADVANCED THE PXC DELIVERY CATHETER ((B)(4)) ALONE FROM THAT POINT. THE PHYSICIAN LATER INDICATED THAT THE ASCENDING AORTA WAS SCRATCHED BY THE PXC CATHETER. HOWEVER, HE WAS UNAWARE OF IT AT THE TIME. BOTH PXC COMPONENTS AND THE TAG DEVICE WERE SUCCESSFULLY DEPLOYED. AFTER TOUCH-UP BALLOONING, A FINAL ANGIOGRAPHIC RUN REVEALED A TYPE A DISSECTION. IT WAS REPORTED THAT THE DISSECTION WAS NOT SEVERE, AND THE PHYSICIAN OPTED TO TAKE A WAIT-AND WATCH APPROACH. THE PROCEDURE CONCLUDED WITHOUT ANY FURTHER COMPLICATIONS. THE PT TOLERATED THE PROCEDURE. THE PHYSICIAN COMMENTED THAT THE EVENT WAS CAUSED BY HIS MANIPULATION OF THE GUIDE WIRE AND PXC CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72480 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 10909462

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other