BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1935526 · Received November 8, 2010

    Report

    Report Number
    2953200-2010-02174
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS/CONCLUSIONS: (PENDING DEVICE EVALUATION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS INSERTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL TORTUOSITY IS UNK AND THERE WAS NO CALCIFICATION. IT WAS REPORTED THAT AN ILIAC LIMB EXTENSION (B)(4) WAS SELECTED TO EXCLUDE AN ILIAC ANEURYSM. NO ISSUES WERE NOTED DURING INSPECTION OF THE DELIVERY SYSTEM PRIOR TO INSERTION. NO ISSUES WERE NOTED DURING THE ADVANCEMENT OF THE DELIVERY SYSTEM. NO TORSION/ROTATION WAS ATTEMPTED. IT WAS REPORTED THAT DURING THE ROTATION OF THE BLUE HANDLE, FOR DEPLOYMENT OF THE STENT GRAFT THE PHYSICIAN FELT RESISTANCE UNTIL THE HANDLE STARTED TO ROTATE FREELY WITH NO RESPONSE OF THE CATHETER. THE FIRST SPRING OF THE OPEN WEB OF THE STENT GRAFT WAS DEPLOYED, HOWEVER SINCE THE REST OF THE GRAFT COULD NOT BE DEPLOYED, THE PHYSICIAN DECIDED TO REMOVE THE DELIVERY SYSTEM. THE FEMORAL ARTERY OF THE PT WAS LARGE IN DIAMETER. THE DEVICE WAS REMOVED WITHOUT ISSUES. THE DEVICE HAS BEEN REC'D BY MEDTRONIC AND THE ANALYSIS IS PENDING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00225018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK