BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5161470 · Received October 20, 2015

    Report

    Report Number
    2017233-2015-00715
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 21, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS INCLUDE COREG, METFORMIN, CARDIZEM, CRESTOR, COUMADIN, LASIX, POTASSIUM, LISINOPRIL, ALBUTEROL, NITROGLYCERIN, BISACODYL, ULTRAM, AND HEPARIN. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO COAGULOPATHY, AND OCCLUSION OF DEVICE OR NATIVE VESSEL. THE REPORTED ¿CRIMPING¿ OF THE DEVICE COULD NOT BE CONFIRMED, AS IMAGES WERE NOT AVAILABLE FOR EVALUATION BY GORE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR A RIGHT COMMON ILIAC ARTERY ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY REPORTED COMPLICATIONS, AND WAS DISCHARGED HOME THE SAME DAY. ON THE SAME EVENING, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH RIGHT LOWER EXTREMITY PAIN, INCLUDING NUMBNESS AND A COOL TEMPERATURE IN HIS RIGHT FOOT. THE PATIENT WAS PLACED ON AN INTRAVENOUS HEPARIN DRIP, AND THE SYMPTOMS SUBSIDED. ON (B)(6) 2015, THE PATIENT UNDERWENT BILATERAL FEMORAL ARTERY RE-EXPLORATION. DURING THE PROCEDURE, BOTH FEMORAL ARTERIES WERE BALLOONED, AND CLOTS WERE EVACUATED BY WAY OF VACUUM. PROCEDURAL ANGIOGRAPHY REVEALED THE LEFT COMMON FEMORAL ARTERY WAS WIDELY PATENT. HOWEVER, THE RIGHT COMMON FEMORAL ARTERY SHOWED REDUCED FLOW. A "CRIMPING" OF THE IPSILATERAL LIMB ((B)(4)/13865698) WAS ALSO REPORTEDLY IDENTIFIED JUST DISTAL TO THE GRAFT BIFURCATION. TWO 12MM X 40MM BARD ATLAS PTA BALLOON CATHETERS WERE ADVANCED TO THE BIFURCATION AND INFLATED IN KISSING FASHION. THE PHYSICIAN THEN IMPLANTED TWO WALLSTENT ENDOPROSTHESES AT THE LEVEL OF THE BIFURCATION. A FINAL ANGIOGRAPH REVEALED IMPROVED FLOW IN BOTH LIMBS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691752 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 13865698

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R