BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENDER CUFF STENT GRAFT, NOT STIFF

    MDR report key: 295365 · Received September 13, 2000

    Report

    Report Number
    2953738-2000-00042
    Event Type
    Injury
    Date Received
    September 13, 2000
    Date of Event
    January 26, 2000
    Report Date
    January 28, 2000
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIV.
    Product Code
    MIH
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28MM X 16MM DIAMETER X 13.5CM LENGTH MEDTRONIC ANEURX BIFURCATED STENT GRAFT WAS INSERTED AND IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 1999. ADD'L PRODUCTS IMPLANTED AT THAT TIME INCLUDED A 16MM X 5.5CM ILIAC STENT GRAFT AND TWO EXTENSION CUFF STENT GRAFTS. DURING ROUTINE POST-OP FOLLOW UP APPROX TWO WEEKS LATER A CT SCAN REVEALED THE PRESENCE OF A FOREIGN BODY THAT WAS DETERMINED TO BE A METAL RUNNER FROM THE STENT DELIVERY SYSTEM (MEDICAL DEVICE REPORT #2953738-2000-00010). THE CT SCAN ALSO DEMONSTRATED AN ENDOLEAK AT THE VERY DISTAL ATTACHMENT ZONE OF THE LEFT ILIAC LIMB. ON 1/26/00, THE PT UNDERWENT SUCCESSFUL ANGIOPLASTY OF THE LEFT ILIAC ARTERY FOR REPAIR OF THE ENDOLEAK, AND ARTERIAL FOREIGN BODY REMOVAL FROM THE RIGHT ILIAC ARTERY. THE PT IS REPORTEDLY DOING WELL. HOWEVER IT HAS BEEN NOTED THAT THE SURGICAL INTERVENTION FOR THE ENDOLEAK HAD NOT BEEN SUBMITTED WITH THE PREVIOUSLY SUBMITTED REPORT. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDER CUFF STENT GRAFT, NOT STIFF AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIV. NA M9958854

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention