BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1011403 · Received March 10, 2008

    Report

    Report Number
    2954310-2008-81642
    Event Type
    Death
    Date Received
    March 10, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A RESEARCH ARTICLE TITLED "SECONDARY AORTOENTERIC FISTULA AFTER ENDOVASCULAR AORTIC INTERVENTIONS: A SYSTEMATIC LITERATURE REVIEW" BY DR. DAVID BERGQVIST, DR. MARTIN BJORCK, AND PUBLISHED IN THE JOURNAL OF VASCULAR INTERVENTION AND RADIOLOGY (VOLUME 19, PAGES 163-165). THE REVIEW REVEALED 16 CASES OF AORTOENTERIC FISTULATION AFTER AORTIC STENT-GRAFTING OR STENT PLACEMENT, IN 14 PATIENTS WITH ABDOMINAL AORTIC ANEURYSM. SIX HAD UNDERGONE ENDOVASCULAR ANEURYSM REPAIR BECAUSE OF WHAT WAS CONSIDERED A "HOSTILE ABDOMEN." THE SYMPTOMS DID NOT DIFFER FROM THOSE IN PATIENTS WITH ARTERIOENTERIC FISTULATION AFTER OPEN AORTIC REPAIR. A DEFECT IN THE STENT-GRAFT OR ITS FUNCTION WAS THE PREDOMINANT CAUSE OF FISTULATION. ONE FISTULA WAS DIAGNOSED AT AUTOPSY, TWO PATIENTS DIED PERIOPERATIVELY AND 13 SURVIVED WITH IN SITU REPAIR OR AN AXILLOBIFEMORAL GRAFT, ALL AFTER REMOVAL OF THE STENT-GRAFT OR STENT. OF THE 6 ENDOVASCULAR ANEURYSM REPAIR CASES, THREE WERE IMPLANTED WITH AN ANCURE ENDOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R