BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1241906 · Received November 19, 2008

    Report

    Report Number
    2953200-2008-01078
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (DEVICE WAS DISCARDED). CONCLUSION: AORTIC NECK WAS THROMBOSED, ANGULATED AND CONTAINED THROMBUS, BILATERAL ILIAC ARTERY CALCIFICATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.4 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 1 MONTH AGO. THE AORTIC NECK WAS THROMBOSED WITH MILD ANGULATION AND CONTAINED THROMBUS. THE ILIAC ARTERIES WERE CALCIFIED BILATERALLY. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED (SEE MFR # 2953200-2008-01077) THERE WAS DIFFICULTY SEATING THE TAPERED TIP OF THE CONTRALATERAL LIMB INTO THE GRAFT COVER DURING PREP, WHICH WAS SUCCESSFUL UPON FURTHER ATTEMPT. THE DELIVERY SYSTEM WAS INSERTED WITHOUT COMPLICATION; HOWEVER, IT WAS DIFFICULT TO GET THE STENT GRAFT TO DEPLOY. THIS REQUIRED THE PHYSICIAN TO PUSH HARDER AND ONCE DEPLOYMENT WAS INITIATED, THE REMAINDER OF THE STENT GRAFT DEPLOYED EASILY. THE DELIVERY SYSTEM WAS DISCARDED UPON COMPLETION OF THE PROCEDURE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00129677

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR