BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7263436 · Received February 12, 2018

    Report

    Report Number
    3007284313-2018-00054
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 17, 2018
    Report Date
    February 12, 2018
    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

    (B)(4). ACCORDING TO THE GORE¿ EXCLUDER¿ AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM RUPTURE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS - PREDNISONE, CIMETIDINE, DEXAMETHASONE, DIPHENHYDRAMINE, ALPRAZOLAM, OMEPRAZOLE, CLOPIDOGREL, EPLERENONE, LEVOTHYROXINE, TORSEMIDE, ESCITALAPRAM, POTASSIUM CHLORIDE, CARVEDILOL.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES. IT WAS REPORTED THE PATIENTS PROXIMAL NECK JUST BELOW THE RENAL ARTERIES WAS VERY SMALL (MEASURING 10 MM) AND EXTREMELY CALCIFIED, SO THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED DISTAL TO THE SMALL, CALCIFIED AREA. THE DEVICE WAS REPORTEDLY DEPLOYED IN ITS INTENDED POSITION WITHIN HEALTHIER TISSUE WITH NO ISSUE. IT WAS REPORTED THAT DURING POST-INFLATION BALLOONING OF THE TRUNK-IPSILATERAL LEG COMPONENT (RLT281214/16623549) USING A QXM¿DICAL Q50-65 STENT GRAFT BALLOON CATHETER (LOT NUMBER UNKNOWN), THE AORTA RUPTURED IN THE AREA BEING BALLOONED. ACCORDING TO THE REPORT, THE BALLOON WAS NOT EXTENDED OUTSIDE THE ENDOPROSTHESIS, AND ONLY ONE BALLOON INFLATION WAS PERFORMED BEFORE THE RUPTURE OCCURRED. IT WAS ALSO REPORTED A 35 CC SYRINGE WAS BEING USED TO INFLATE THE BALLOON, BUT THE INFLATION VOLUME IS UNKNOWN. IT WAS REPORTED THAT AFTER THREE AORTIC EXTENDER COMPONENTS WERE IMPLANTED, EXTRAVASATION WAS STILL SEEN FROM THE RUPTURE. A FOURTH AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY INTENTIONALLY COVERING THE LEFT RENAL ARTERY, LEAVING THE RIGHT RENAL ARTERY UNCOVERED AND MAINTAINING PERFUSION. IT WAS REPORTED EXTRAVASATION WAS STILL SEEN FROM THE RUPTURE, SO A FIFTH AORTIC EXTENDER COMPONENT WAS IMPLANTED WITHIN THE PREVIOUSLY IMPLANTED DEVICES. ACCORDING TO THE REPORT, AT THIS POINT THE PATIENTS BLOOD PRESSURE HAD STABILIZED, BUT EXTRAVASATION WAS STILL SEEN FROM THE RUPTURE. IT WAS REPORTED THAT ALL POSSIBLE INTERVENTION HAD BEEN PERFORMED FROM AN ENDOVASCULAR STANDPOINT, AND THE PATIENT WAS REPORTED TO NOT BE A CANDIDATE FOR OPEN REPAIR DUE TO THE AMOUNT AND LOCATION OF THE EXCESSIVE CALCIFICATION IN THE PROXIMAL AORTIC NECK. ACCORDING TO THE REPORT, THE PROCEDURE WAS CONCLUDED WITH THE PLAN OF MONITORING THE PATIENT POST-OPERATIVELY. IT WAS REPORTED THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106725 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 16623549

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R