BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT SYSTEM

    MDR report key: 2000728 · Received February 16, 2011

    Report

    Report Number
    2953200-2011-00413
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (PERFORATION). EVALUATION, RESULTS AND CONCLUSION: (SMALL IN DIAMETER AND CALCIFIED DISTAL AORTA). (REINSERTION OF KINKED DEVICE, USE OF THORACIC DEVICE IN THE ABDOMINAL).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.3 CM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS LARGE, RANGING FROM 35 MM IN DIAMETER AT THE RENAL ARTERIES, ENLARGED TO 38 MM, AND WAS THEN 35 MM IN DIAMETER ABOVE THE AAA OVER A LENGTH OF 22 MM; THE NECK ALSO WAS MODERATELY ANGULATED AND HAD THROMBUS AND CALCIFICATION. ILIAC ARTERIES WERE MILDLY CALCIFIED, NON-TORTUOUS, AND 14 MM IN DIAMETER ON THE RIGHT AND 16 MM IN DIAMETER ON THE LEFT. ACCESS VESSELS WERE CALCIFIED AND SLIGHTLY LARGER THAN 6 MM IN DIAMETER. THE PT WAS NOT AN OPEN-REPAIR CANDIDATE. THE TALENT BIFURCATED STENT GRAFT WAS ABLE TO BE DELIVERED UP THE RIGHT SIDE AND DEPLOYED WITHOUT ISSUES. DUE TO THE VERY LARGE NECK, A TALENT THORACIC GRAFT WAS PLANNED TO BE PLACED PROXIMALLY. THE TAA GRAFT DEVICE WAS ADVANCED UP THE LEFT SIDE AND ABLE TO BE DELIVERED ALL THE WAY TO THE AAA BUT WAS GETTING CAUGHT AT THE AORTIC BIFURCATION. THE DELIVERY SYSTEM WAS REMOVED FROM THE PT AND THERE WAS A SMALL CRIMPING/KINK OF THE DEVICE NOTED, BUT THE DELIVERY SYSTEM WAS ADVANCED ON THE RIGHT SIDE. THE TAA DEVICE STILL COULD NOT BE ADVANCED VIA THE RIGHT SIDE. A CONDUIT WAS THEN PLACED SUCCESSFULLY, AND THE TAA GRAFT WAS DELIVERED AND DEPLOYED WITHOUT ISSUES. AFTER REMOVING THE TAA DELIVERY SYSTEM, THE PATIENT'S PRESSURE STARTED DROPPING, AND A HOLE/TEAR IN THE AORTIC BIFURCATION WAS NOTED. A RELIANT BALLOON WAS INSERTED TO HELP STABILIZE THE PT, AND THE HOLE WAS REPAIRED. THE CONTRALATERAL LIMB WAS THEN PLACED WITHOUT ISSUES. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. (REF MFR 2953200-2011-00412).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00525386

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention