BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1890201 · Received October 22, 2010

    Report

    Report Number
    2953200-2010-02025
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS AND CONCLUSIONS: OTHER -LOT NUMBER, IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. DEATH WAS UNRELATED TO THE ENDOVASCULAR PROCEDURE. NONE OF THE EVENTS IN THE ARTICLE MATCH EVENT INFO ALREADY KNOWN TO MEDTRONIC. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFO RELATED TO EACH EVENT RELATED TO ANEURX DEVICES, SUCH AS THE LOT NUMBER, IMPLANT DATE, AND EXPLANT DATE. NO REPLY HAS BEEN RECEIVED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: IMPLANT DEGENERATION AND POOR HEALING AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS: AN ANALYSIS OF EXPLANTED STENT-GRAFTS, J ENDOVASC THER 2006; 13: 457-467. THIS JOURNAL ARTICLE REPORTED THE FOLLOWING INFO: 12 EXPLANTED STENT GRAFTS WERE ANALYZED FOR FAILURE MECHANISMS. THE STENT GRAFTS STUDIED INCLUDED MEDTRONIC ANEURX (N=2) AND TALENT (N=5) STENT GRAFTS AND STENT GRAFTS FROM ANOTHER MFR. ONE EXPLANT WAS FROM A PT WITH AN ANEURX STENT GRAFT (MFR REPORT # 2953200-2010-02024), WHICH WAS IMPLANTED FOR 1.5 MONTHS AND EXPLANTED DURING AN AUTOPSY. IT WAS REPORTED THAT THE PT EXPIRED DUE TO PARALYTIC ILEUS AND SEVERE MELENA, AND THEREFORE, THE CAUSE OF THE PT'S DEATH WAS NOT RELATED TO THE ENDOVASCULAR PROCEDURE. DAMAGE ON THE ANEURX STENT GRAFT WAS LIMITED TO A FEW BROKEN METALLIC RINGS OF THE STENT EXOSKELETON. A SECOND EXPLANT WAS FROM ANOTHER PT WITH AN ANEURX STENT GRAFT, WHICH WAS IMPLANTED FOR 27 MONTHS AND EXPLANTED DURING AN AUTOPSY. THE PT EXPIRED DUE TO BRONCHOPNEUMONIA AND SEPSIS. IT WAS REPORTED THAT THERE WAS POOR APPOSITION OF THE STENT GRAFT WITH THE VESSEL WALL AND THAT THERE WAS STENT GRAFT INFOLDING. THE CAUSE OF THE PT'S DEATH WAS NOT RELATED TO THE ENDOVASCULAR PROCEDURE. DAMAGE ON THE ANEURX STENT GRAFT WAS LIMITED TO A FEW BROKEN METALLIC RINGS OF THE STENT EXOSKELETON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR