BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1078608 · Received July 17, 2008

    Report

    Report Number
    2954310-2008-81656
    Event Type
    Death
    Date Received
    July 17, 2008
    Date of Event
    January 1, 1994
    Report Date
    July 8, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERFORMANCE ISSUES REPORTED IN THE CASE STUDY WERE: AAA RELATED DEATHS: ACCORDING TO THE ARTICLE THERE WAS 5 AAA-RELATED DEATHS DOCUMENTED IN THE DATABASE. THERE WAS 1 REPORT OF VASCULAR COMPLICATIONS DESCRIBED AS RUPTURE OF THE EXTERNAL ILIAC ARTERY RESULTING FROM THE WITHDRAWAL OF THE INTRODUCER SHEATH WHICH WAS RESOLVED WITH SUTURES. RUPTURES: THERE WERE 7 POSTOPERATIVE AAA RUPTURES IN THE DATABASE. ENDOLEAKS: THERE WERE ENDOLEAKS REPORTED WITHIN 30 DAYS OF IMPLANT, ENDOLEAKS WITHIN 1 YEAR AND 107 WITHIN FOUR YEARS. SOME OF THESE ENDOLEAKS CONTRIBUTED TO GROWTH OF THE ANEURYSM SAC. AS PART OF THE INVESTIGATION, ATTEMPTS TO OBTAIN SPECIFIC DETAILS FROM THE AUTHOR REGARDING THE ANCURE DEVICES AND ANY ASSOCIATED COMPLICATIONS WERE UNSUCCESSFUL. WE ARE FILING AN MDR AT THIS TIME SINCE WE CANNOT DEFINITIVELY REFUTE THE POSSIBLE INVOLVEMENT OF THE ANCURE DEVICE NOR CONFIRM THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    THE FOLLOWING JOURNAL ARTICLE FROM 2006 WAS REVIEWED: ARTICLE CITATION: SICARD, G.A., ZWOLAK, R.M., SIDAWY, A.N., WHITE, R.A., SIAMI, F.S. (2006) ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: LONG-TERM OUTCOME MEASURES IN PTS AT HIGH RISK FOR OPEN SURGERY. JOURNAL FOR VASCULAR SURGERY. 44:2, 229-236. THIS ARTICLE REVIEWED DATABASE CREATED BY THE SOCIETY FOR VASCULAR SURGERY IN 1998 TO EVALUATE TO 4-YEAR OUTCOME OF PTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE DATABASE WAS POPULATED WITH RESULTS FROM THE FIVE MULTICENTER, CONTROLLED CLINICAL TRIALS USED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION FOR CLINICAL APPROVAL OF THE ANCURE AND ITS COMPETITOR'S ENDOVASCULAR GRAFTS. ANCURE REPRESENTED SUCCESSFUL IMPLANTS IN THE DATABASE AND 25 OF THE 61 CONVERSIONS TO OPEN REPAIR.

    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 Required Intervention