BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 4093566 · Received September 16, 2014

    Report

    Report Number
    2953200-2014-01837
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT DURING FOLLOW UP IT WAS DISCOVERED THAT THE TALENT DEVICE HAD MIGRATED COMPLETELY INTO THE SAC AND A TYPE IA ENDOLEAK WAS IDENTIFIED. THE MIGRATION WAS DUE TO NECK DILATATION. THE PHYSICIAN DECIDED TO PERFORM AN INTERVENTION AND CUFF UP TO THE RENAL ARTERIES SINCE THE ANEURYSM WAS INCREASING IN SIZE. TWO VALIANT STENT GRAFTS WERE USED FOR THE INTERVENTION. DURING THE REMOVAL OF THE FIRST VALIANT DELIVERY SYSTEM THE NOSE CONE BECAME LODGED INTO THE PREVIOUSLY IMPLANTED LIMB. THE NOSE CONE BROKE LOOSE AND FLOATED UP INTO THE THORACIC AREA. THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE NOSE CONE AFTER A LOT OF EFFORT. DUE TO THE REMOVAL DIFFICULTIES THE PATIENT SUFFERED A LARGE AMOUNT OF BLOOD LOSS AND THE PHYSICIAN HAD TO SURGICALLY REPAIR THE BATTERED FEMORAL ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. THE REVIEW OF SEVERAL STILL ANGIO IMAGES REVEALED THAT THE TALENT BIFURCATE WAS POSITIONED WITHIN THE BOTTOM OF THE AAA SAC. THE DEVICE APPEARED TO HAVE FOLDED OVER ITSELF AT THE FLOW DIVIDER AND WAS KINKED APPROXIMATELY 90 DEG TO THE LIMBS. THE PATENCY THOROUGH BOTH LIMBS COULD NOT BE ASSESSED FROM THE IMAGES PROVIDED. IMAGES DURING THE VALIANT CUFF IMPLANT AND DELIVERY SYSTEM REMOVAL, INCLUDING THE REPORTED TIP DETACHMENT, WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572817 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00437430

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention