BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143114 · Received May 29, 2013

    Report

    Report Number
    3007284313-2013-00035
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    October 23, 2012
    Report Date
    May 14, 2013
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER COMPONENTS INCLUDED IN THIS REPORT: PXC181000/10527189, PXA23030/UNK, PXC21400/UNK. IMAGING EVALUATION FINDINGS: (B)(6) 2012 - INTRA-OPERATIVE ANGIOGRAM FRACTURE, OR TEAR/DISRUPTION IN THE GRAFT MATERIAL COULD NOT BE IDENTIFIED WITH AVAILABLE IMAGING. ADDITIONAL IMPLANTED DEVICE APPEARS TO COVER THE RIGHT HYPOGASTRIC. CONTRAST APPEARS VISIBLE IN THE RIGHT HYPOGASTRIC. RESULTS - A REVIEW OF THE MANUFACTURING RECORDS FOR THE PXC181200 AND PXC181000, DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. (PLEASE NOTE: EVALUATIONS COULD NOT BE PERFORMED ON THE PXA230300 AND PXC121400 DEVICES, AS THEIR RESPECTIVE LOT/SERIAL NUMBERS WERE NOT AVAILABLE). CONCLUSIONS: PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), RECOMMENDED ENDOPROSTHESIS OVERSIZING RELATIVE THE VESSEL IS APPROXIMATELY 7-25% FOR THE CONTRALATERAL LEG ENDOPROSTHESIS. ADDITIONALLY, THE AORTIC EXTENDER ENDOPROSTHESIS (AORTIC EXTENDER) PROVIDES AN EXTENSION OF APPROXIMATELY 1.6 CM OR 2.2 CM OF THE LEADING (PROXIMAL) END OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (TRUNK). THE GORE EXCLUDER AAA ENDOPROSTHESIS IFU STATES: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK, RUPTURE, AND OCCLUSION OF NATIVE VESSEL.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH SIX GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A TRUNK-IPSILATERAL LEG COMPONENT AND TWO CONTRALATERAL LEG COMPONENTS WERE DEPLOYED WITHOUT INCIDENT. HOWEVER, WHILE TOUCH-UP BALLOONING THE GRAFT SYSTEM IN THE RIGHT COMMON ILIAC, IT WAS REPORTED THE GRAFT (PXC181200/10366183) EXPANDED AND POPPED. AN ANGIOGRAPHIC RUN REVEALED WHAT WAS THOUGHT TO BE A TEAR IN THE GRAFT MATERIAL APPROXIMATELY 3 CM FROM THE DISTAL END OF THE DEVICE, ALTHOUGH AN ILIAC ARTERY RUPTURE COULD NOT BE RULED OUT. THE PHYSICIAN ATTEMPTED TO RE-LINE THE GRAFT WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT (PXC1810000). HOWEVER, AFTER BALLOONING THE DEVICE, AN ANGIOGRAPHIC RUN REVEALED A CONTINUED LEAK. IT WAS THOUGH THAT THE LEAK MAY HAVE BEEN FLOWING AROUND THE DISTAL END OF THE TWO 18 MM GRAFT COMPONENTS. THE PHYSICIAN THEN ATTEMPTED TO LINE THE GRAFT SYSTEM FURTHER WITH A 23 MM AORTIC EXTENDER COMPONENT (PXA230300). HOWEVER, THE AORTIC EXTENDER DID NOT REACH THE AREA WHERE THE 18 MM GRAFT LEAKS WERE ORIGINATING. FINALLY, THE PHYSICIAN IMPLANTED AN ADDITIONAL CONTRALATERAL LEG COMPONENT (PXC121400). THE PATIENT'S RIGHT HYPOGASTRIC ARTERY WAS INTENTIONALLY COVERED. A FINAL ANGIOGRAPHIC RUN REVEALED THE LEAK INTO THE PERITONEAL HAD STOPPED, BUT CONTRAST DID CONTINUE TO FLOW FROM THE RIGHT COMMON ILIAC ARTERY, BETWEEN THE 18- AND 12 MM GRAFTS, AND EXITED THROUGH THE HYPOGASTRIC. THE PHYSICIAN HAS DECIDED TO TAKE A WAIT-AND-WATCH APPROACH, AND WILL RE-EVALUATE THE PATIENT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235262 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE ASSOCIATES 10366183

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other HYDROCHLOROTHIAZIDE| BENAZEPRIL| CHOLECALCIFEROL| ATENOLOL| WARFARIN SODIUM| SIMVASTATIN| CALCIUM CARBONATE