BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3010978 · Received March 8, 2013

    Report

    Report Number
    2953161-2013-00032
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. "USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES." THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES: FOLLOW THE MANUFACTURER'S RECOMMENDED METHOD FOR SIZE SELECTION, PREPARATION AND USE OF AORTIC AND ILIAC DILATION BALLOONS. CAREFULLY INFLATE THE BALLOON TO AVOID COMPLICATIONS. ADVANCE AND INFLATE THE APPROPRIATE SIZE PTA BALLOON CATHETER TO SEAT THE ILIAC END OF THE ENDOPROSTHESIS. FOLLOW THE MANUFACTURER'S RECOMMENDED METHOD FOR SIZE SELECTION, PREPARATION AND USE OF PTA BALLOONS. CAREFULLY INFLATE THE BALLOON TO AVOID COMPLICATION. ADDITIONALLY THE IFU SPECIFIES: THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: LEAK: PENDING RUPTURE OR RUPTURED ANEURYSMS. THE IFU ADDITIONALLY STATES: ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM RUPTURE AND DEATH, RENAL (E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE), VASCULAR SPASM OR VASCULAR TRAUMA (E.G., ILIO-FEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE, DEATH).

    Description of Event or Problem · 1

    ON (B)(6) 2013, UNDERWENT ENDOVASCULAR REPAIR FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. POST IMPLANT OF THE TRUNK IPSILATERAL LEG COMPONENT ON THE RIGHT SIDE, THE CONTRALATERAL SIDE WAS EXTENDED WITH TWO GORE ILIAC EXTENDER COMPONENTS. A RELIANT BALLOON CATHETER WAS USED TO PERFORM TOUCH-UP BALLOONING DISTALLY ON THE LEFT SIDE. IT WAS REPORTED THAT THE PHYSICIAN OVER INFLATED THE BALLOON CAUSING A RUPTURE OF THE LEFT EXTERNAL ILIAC ARTERY. AN ADDITIONAL ILIAC EXTENDER WAS IMPLANTED TO REPAIR THE RUPTURED PORTION OF AT THE ORIGIN OF THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. THE PATIENT WAS ADMINISTERED VASOPRESSORS AND RECEIVED TRANSFUSION; HOWEVER, BLOOD PRESSURE DID NOT IMPROVE. THE PATIENT EXPIRED EARLY IN THE MORNING. THE CAUSE OF DEATH WAS PRE-EXISTING ANEURYSM RUPTURE. THE SOURCE OF THE BLOOD SUPPLY TO THE RUPTURED ANEURYSM WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100627 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 10819922

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| O| R| S