BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1933748 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02562
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (ENDOLEAK) AND (UNK CAUSE OF ENDOLEAK). CONCLUSIONS: (UNK CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 27 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. THE ILIAC ARTERIES WERE ANEURYSMAL. IT WAS REPORTED THAT DURING A ROUTINE F/U A DISTAL TYPE 1 ENDOLEAK ON THE RIGHT SIDE WAS SEEN. THE ILIAC ANEURYSM HAD DEVELOPED AROUND THE DISTAL PORTION OF THE CONTRALATERAL LIMB AND RESULTED IN LOSS OF SEAL (SEE MFR # 2953200-2010-02561). THE ILIAC ANEURYSM WAS ATTRIBUTED TO DISEASE PROGRESSION. THE DECISION WAS MADE TO EMBOLIZE THE RIGHT HYPOGASTRIC ARTERY AND EXTEND WITH A TALENT LIMB. AFTER THE TALENT LIMB WAS IMPLANTED THERE WAS A SMALL PIN HOLE THAT RESULTED IN A TYPE 3 ENDOLEAK. THE TALENT LIMB WAS RELINED WITH AN ADDITIONAL STENT GRAFT AND SUCCESSFULLY RESOLVED THE ENDOLEAK. 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 V00481718

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention