BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALEN THORACIC STENT GRAFT SYSTEM

    MDR report key: 1211081 · Received October 24, 2008

    Report

    Report Number
    2953200-2008-00970
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION - EVAL RESULTS - GRAFT WAS INACCURATELY DELIVERED BY THE USER.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED DURING INITIAL DEPLOYMENT OF THE PROXIMAL MAIN DEVICE THE PLACEMENT WAS SIGNIFICANTLY PROXIMAL TO THE CAROTID ARTERY AND APPEARED TO BE GRADUAL AND DELIBERATE. IT WAS NOTED THAT THE BARE SPRING ON THE LESSER CURVE WAS IN A SUBOPTIMAL POSITION (MISALIGNED OPENING). THE PHYSICIAN PULLED THE ENTIRE DELIVERY SYSTEM AS ONE UNIT TO CORRECT THE POSITION OF THE LOWER BARE SPRING RESULTING IN THE BARE SPRING ON THE LESSER CURVE TO CORRECT ITSELF, HOWEVER, THIS RESULTED IN THE STENT GRAFT TO LAND WELL BELOW THE INTENDED LANDING ZONE WHICH WAS DISTAL TO THE LEFT SUBCLAVIAN. THE PHYSICIAN PLACED A PROXIMAL EXTENSION PIECE, FINAL RESULTS WERE GOOD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALEN THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00158550

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention