BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYRDO

    MDR report key: 1170738 · Received September 15, 2008

    Report

    Report Number
    2953200-2008-00810
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SMALL ILIAC ARTERY AND SEVERE CALCIFICATION. GRAFT COVER KINKED. DEVICE DISCARDED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNK. VESSEL MORPHOLOGY WAS SMALL ILIAC ARTERY AND SEVERE CALCIFICATION. IT WAS REPORTED THAT THE STENT GRAFT WAS UNABLE TO BE ADVANCED TO THE INTENDED LANDING ZONE AND DUE TO THE SMALL ILIAC ARTERIES, THE STENT GRAFT DELIVERY CATHETER KINKED. THE DELIVERY CATHETER WAS REMOVED FROM THE PT. THE PHYSICIAN BELIEVES THAT THE KINK IN THE STENT GRAFT DELIVERY CATHETER WAS DUE TO EXCESSIVE PUSHING OF THE DELIVERY CATHETER. THE PHYSICIAN COMPLETED THE CASE BY DILATING THE ARTERY AND ADVANCING ANOTHER ANEURX STENT GRAFT SYSTEM SUCCESSFULLY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYRDO MIH MEDTRONIC CARDIOVASCULAR NA V00124986

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK