BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1873147 · Received October 14, 2010

    Report

    Report Number
    2017233-2010-00459
    Event Type
    Death
    Date Received
    October 14, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 14, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE USED: (B)(4). ACCORDING TO THE INSTRUCTIONS FOR USE, KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SIGNIFICANT THROMBUS AND / OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. THE U.S. CLINICAL STUDIES QUANTIFY SIGNIFICANT THROMBUS AS THROMBUS GREATER THAN OR EQUAL TO 2 MM IN THICKNESS AND / OR GREATER THAN OR EQUAL TO 25% OF THE VESSEL CIRCUMFERENCE IN THE INTENDED SEAL ZONE OF THE AORTIC NECK.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. THROMBUS WAS PRESENT IN THE PROXIMAL NECK AT AORTA AND THE ENTIRE WALL OF THE COMMON ILIAC ARTERIES. ON (B)(6) 2010, THIS PT REPORTED A FEELING OF ABDOMINAL DISTENSION AND PAIN. COMPUTED TOMOGRAPHY WAS PERFORMED, BUT THE PT SUFFERED RESPIRATORY ARREST DURING THE PROCEDURE. AN EMERGENCY SURGERY WAS PERFORMED FOR AN INTESTINAL RESECTION. HOWEVER, THE PT HAD CARDIAC ARREST AND EXPIRED DURING LAPAROTOMY. AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS EXTENSIVE PERIPHERAL VASCULAR EMBOLIZATION WHICH OCCURRED DURING THE INITIAL PROCEDURE AND BOWEL NECROSIS. THE PHYSICIAN BELIEVES THAT BOWEL NECROSIS MAY HAVE BEEN CAUSED BY INJECTING THE CONTRAST AGENT IN A RETROGRADE FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 8025976

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death BOSMIN WAS ADMINISTERED TO RESTORE RESPIRATION.