BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1960326 · Received November 17, 2010

    Report

    Report Number
    2953200-2010-02254
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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

    (B)(4): RESULTS AND CONCLUSION: (SMALL AND CALCIFIED AORTIC BIFURCATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A 5.0 CM ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS CIRCUMFERENTIAL CALCIUM, THE AORTIC NECK WAS 22 MM IN DIAMETER PROXIMALLY, 21 MM IN DIAMETER DISTALLY WITH HEAVY CALCIUM. BILATERALLY, THE ILIAC ARTERIES WERE OVER 9 MM IN DIAMETER. IT WAS REPORTED THAT THE ILIAC LIMB WAS ADVANCED THROUGH A 16 FR INTRODUCER SHEATH AND DEPLOYED WITHOUT ISSUE. IT WAS REPORTED THAT UPON REMOVAL OF THE ILIAC STENT GRAFT DELIVERY SYSTEM, IT WAS CAUGHT ON THE SHEATH AND COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE SHEATH AND THE DELIVERY SYSTEM AS ONE UNIT. UPON INSPECTION OF THE DEVICE, IT WAS FOUND KINKED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION THERE WAS NO PATIENT INJURY. 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 MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00522060

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR