BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1943780 · Received December 21, 2010

    Report

    Report Number
    2953200-2010-02594
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: OCCLUSION. MILD TORTUOUSITY, MILD TO MODERATE CALCIFICATION. EVAL, CONCLUSION: MILD TORTUOUSITY, MILD TO MODERATE CALCIFICATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK HAD 30 DEGREE ANGULATION, IT WAS 16 MM IN DIAMETER; HOWEVER, ON IVUS IT WAS LARGER THAN 18 MM AND IT WAS 8 MM IN LENGTH. THE ILIAC ARTERIES HAD MILD TO MODERATE CALCIFICATION AND MILD TORTUOSITY. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE 1 ENDOLEAK (SEE MFR # 2953200-2010-02593). AN ANEURX AORTIC CUFF WAS IMPLANTED, WHICH RESOLVED THE ENDOLEAK. ON (B)(6) 2010 THE PT PRESENTED WITH ABDOMINAL AND BACK PAIN. A CT WAS PERFORMED AND REVEALED THAT THERE WAS THROMBOSIS THROUGHOUT THE ENTIRE STENT GRAFT SYSTEM AND THERE WAS NO BLOOD FLOW THROUGH THE STENT GRAFT (SEE MFR # 2953200-2010-02595); HOWEVER, THERE WAS SOME COLLATERAL FLOW FEEDING THE LOWER EXTREMITIES. A VASCULAR BYPASS WAS PERFORMED ON THE SAME WEEK THE PT PRESENTED. 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 V00547688

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention