BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1843540 · Received September 22, 2010

    Report

    Report Number
    2953200-2010-01789
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION). RESULTS AND CONCLUSION: (CALCIFIED AORTIC NECK, TORTUOUS, SEVERELY CALCIFIED AND STENOSED VESSELS).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 25-27 MM IN DIAMETER, CALCIFIED, AND HAD MILD ANGULATION AND THROMBUS. THE VESSELS WERE TORTUOUS, SEVERELY CALCIFIED AND STENOSED BY THE CALCIFICATION. ALTHOUGH THE LEFT ILIAC ARTERY WAS PRE-DILATATED WITH A BALLOON, THE TALENT BIFURCATED DEVICE COULD NOT BE ADVANCED THROUGH THE CALCIFIED VESSELS AND IT KINKED. THE DECISION WAS MADE TO CONVERT THE DEVICE TO AN AORTO-UNI-ILIAC SYSTEM BY PLACEMENT OF A TALENT CONVERTER. NO ILIAC INJURY WAS NOTED AT THIS TIME. AN ANGIOGRAM WAS SHOT FOR DETERMINING THE LOCATION OF THE HYPOGASTRIC ARTERY, IT WAS NOTED THAT THERE WAS A PERFORATION AND SEVERE BLEEDING OF THE LEFT ILIAC ARTERY (SEE MFR # 2953200-2010-01790). A TALENT LIMB WAS PLACED DIRECTLY ONTO THE BLEEDING SITE, FOLLOWED BY ANOTHER TALENT LIMB WHICH WAS PLACED BETWEEN THE CONVERTER AND THE LIMB AND THIS PIECE WAS USED TO CONTROL THE BLEEDING. HOWEVER, THE LIMB THAT WAS INTENDED TO CONTROL THE BLEEDING WAS INEFFECTIVE, THEREFORE THE DECISION WAS MADE TO SURGICALLY CONVERT THE PT TO OPEN REPAIR (SEE MFR # 2953200-2010-01791 AND MFR # 2953200-2010-01792). 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 V00458075

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention