BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 1772388 · Received July 23, 2010

    Report

    Report Number
    2953200-2010-01385
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - ENDOLEAK; SIGNIFICANT TORTUOUS AORTIC ARCH, MODERATE AMOUNT OF THROMBUS; INJECTOR TUBING DISCONNECTED AND RELEASED CONTRAST. CONCLUSION - SIGNIFICANT TORTUOUS AORTIC ARCH, MODERATE AMOUNT OF THROMBUS. INJECTOR TUBING DISCONNECTED AND RELEASED CONTRAST.

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 6.6 CM THORACIC AORTIC ANEURYSM. THE AORTIC ARCH HAD SIGNIFICANT TORTUOSITY, AND THERE WAS A MODERATE AMOUNT OF THROMBUS DISTAL TO THE ANEURYSM. ILIAC VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT WHEN DEPLOYING THE FIRST TALENT CAPTIVIA STENT GRAFT (MFR REPORT #2953200-2010-01385), THE INJECTOR TUBING DISCONNECTED AND RELEASED CONTRAST EVERYWHERE, INCLUDING ONTO THE PHYSICIAN. CONSEQUENTLY, THE PHYSICIAN INADVERTENTLY PULLED THE STENT GRAFT DOWNWARD APPROXIMATELY 2 CM, ALTHOUGH THE FINAL POSITION OF THE GRAFT ENDED UP 1 CM AWAY FROM THE SUBCLAVIAN ARTERY. A DISTAL EXTENSION STENT GRAFT WAS THEN DEPLOYED AND BALLOONED WITHOUT ISSUES. ON THE COMPLETION ANGIOGRAM, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO ADD A PROXIMAL EXTENSION STENT GRAFT (MFR REPORT #2953200-2010-01386), WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK BUT PARTIALLY COVERED THE SUBCLAVIAN ARTERY IN ORDER TO GAIN A PROXIMAL SEAL. NO INTERVENTION WAS PERFORMED FOR THE PARTIAL VESSEL COVERAGE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. PLEASE NOTE THAT THIS DEVICE, THE TALENT CAPTIVIA STENT GRAFT SYSTEM, IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT TALENT THORACIC STENT GRAFT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00420039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention