BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5009487 · Received August 18, 2015

    Report

    Report Number
    3007284313-2015-00087
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    July 19, 2015
    Report Date
    August 26, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONCOMITANT MEDICAL PRODUCTS ARE THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXC121200/13287588, PXC141200 /13426725, PXC141400/13580484) AND TWO GORE® VIABAHN® ENDOPROSTHESIS (VBC101002/12878005, VBC131002/13685144). THE THERAPY DATE WAS (B)(6) 2015. THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), THE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE GORE EXCLUDER AAA ENDOPROSTHESIS MAY OCCUR BUT ARE NOT LIMITED TO ENDOLEAK AND DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2015 THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM (RMT261418/12505275) AND THREE GORE EXCLUDER AAA ENDOPROSTHESIS (PXC121200/13287588, PXC141200 /13426725, PXC141400/13580484) TOGETHER WITH TWO GORE VIABAHN ENDOPROSTHESIS WITH FOR TREATMENT OF A MASSIVE ANEURYSM FROM THE ABDOMINAL ARTERY TO THE RIGHT FEMORAL ARTERY. ACCESS FOR EXCLUDER DEVICES WAS PERFORMED FROM THE RIGHT FEMORAL ARTERY AND TWO VIABAHN DEVICES IN THE RIGHT FEMORAL ARTERY FROM THE POPLITEAL ARTERY. IT WAS STATED THAT THE RIGHT FEMORAL ARTERY ANEURYSM STARTED TO RUPTURE BEFORE THE OPERATION AND THE CONDITIONS OF BLOOD VESSEL WERE POOR. THE POST-DEPLOYMENT ANGIOGRAPHY REPORTEDLY SHOWED A SMALL TYPE I ENDOLEAK FROM THE DISTAL PORTION OF THE GORE VIABAHN ENDOPROSTHESIS, BUT WITHOUT ENDOLEAK IN THE PROXIMAL PORTION OF THE GORE EXCLUDER AAA ENDOPROSTHESIS. AFTER THE OPERATION, IT WAS STATED THAT THE PATIENT EXPERIENCED POST-OPERATIVE OLIGOCHROMEMIA AND A 1G DECREASE OF HEMACHROME PER DAY, BUT IMPROVED AFTER CLINICAL TREATMENT BY TRANSFUSION AND DRUG ADMINISTRATION. THE BEDSIDE ULTRASOUND ON UNKNOWN DATE AFTER THE OPERATION REVEALED PERITONEAL EFFUSION. A MIXED ENCLOSED MASS WAS REVEALED IN THE RIGHT UPPER ABDOMEN, IT IS NOT CLEAR OF THE SOURCE OF THE MASS AND NEEDS FURTHER INSPECTION TO CONFIRM. THE ABDOMINAL ANEURYSM WITH THROMBUS WAS DETECTED AFTER THE STENT GRAFT BEING IMPLANTED. THE RIGHT FEMORAL ARTERY IMPLANTED WITH STENT GRAFT WAS DETECTED WITH MIXED ENCLOSED MASS. BOTH LIMB ARTERIES WERE DETECTED WITH ATHEROSCLEROSIS. ON EARLY (B)(6) 2015, THE PATIENT COMPLAINED ABDOMINAL PAIN, THE BLOOD PRESSURE DROPPED DOWN SHARPLY DUE TO MASSIVE HAEMORRHAGE AND THE PATIENT EXPIRED. THE REASON WAS REPORTEDLY UNCERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545988 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12505275

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death