BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1884612 · Received October 19, 2010

    Report

    Report Number
    2953200-2010-02002
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (GRAFT OCCLUSION), (NARROW AORTIC BIFURCATION), (USE OF THE DEVICE TO TREAT AN ILIAC ANEURYSM WITHOUT AN ABDOMINAL AORTIC ANEURYSM). CONCLUSIONS: (NARROW AORTIC BIFURCATION), (USE OF THE DEVICE TO TREAT AN ILIAC ANEURYSM WITHOUT AN ABDOMINAL AORTIC ANEURYSM; USE OF THE DEVICE IN A NARROW AORTIC BIFURCATION).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.7 CM RIGHT ILIAC ARTERY ANEURYSM APPROX 2 MONTHS AGO. THE AORTIC BIFURCATION MEASURED 19 MM IN DIAMETER, AND THE VESSELS HAD MILD TORTUOSITY AND MILD CALCIFICATION. IT WAS REPORTED THAT APPROX 1 MONTH POST-IMPLANTATION, A FOLLOW-UP CT DEMONSTRATED THAT THERE WAS AN OCCLUSION IN THE BIFURCATED STENT GRAFT IN THE UNSUPPORTED AREA. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING AN ILIAC LIMB AND A BALLOON-EXPANDABLE BARE METAL STENT. HOWEVER, THE IMPLANTATION OF THE ILIAC LIMB AND BALLOON-EXPANDABLE STENT ENDED UP OCCLUDING THE CONTRALATERAL ILIAC STENT GRAFT (MFR REPORT #2953200-2010-02003). THE PHYSICIAN THEN ELECTED TO PERFORM A FEMORAL-TO-FEMORAL BYPASS, WHICH SUCCESSFULLY RESOLVED THE OCCLUSION. THE PHYSICIAN STATED THAT THE CAUSE OF THE OCCLUSION IS MOST LIKELY DUE TO THE SMALL IN DIAMETER AORTIC BIFURCATION. 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 - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00447718

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention