BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT AAA

    MDR report key: 4221969 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02292
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY 4.5 YEARS POST INDEX, THE PATIENT PRESENTED TO THE ER COMPLAINING OF BACK PAIN. A REVIEW OF CT IMAGES REVEALED THAT THE STENT GRAFT HAD MIGRATED DISTALLY, WITH NO ENDOLEAK NOTED. IN ADDITION, AN OCCLUSION OF THE IPSILATERAL LIMB WAS NOTICED ON THE FILMS. THE PROXIMAL AORTIC NECK WAS MEASURED TO BE 27MM IN DIAMETER, THE DISTAL NECK 34 MM IN DIAMETER, WITH A LENGTH OF OVER 8 MM. THE PATIENT WILL BE MONITORED AND FURTHER INTERVENTION DECISION IS PENDING FROM THE PATIENT. THE PHYSICIAN BELIEVES THE CAUSE OF THE MIGRATION TO BE DISEASE PROGRESSION/AORTIC DILATATION, AND THE OCCLUSION TO LIMB KINKING/OVERSIZING AT THE TIME OF DEPLOYMENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF RETURNED IMAGES FROM 4-½ YEARS POST-IMPLANT REVEALED THAT THE TALENT BIFURCATE IS CURRENTLY 3CM BELOW THE LOWEST RENAL ARTERY. THE STENT GRAFT PROXIMAL OD IS 36MM. THE MAXIMUM DIAMETER AORTA, MEASURED 1-2CM BELOW THE RENALS ARTERIES MEASURES 43MM. THE IPSILATERAL LIMB WAS PLACED INTO THE RIGHT ILIAC; THE IPSILATERAL LIMB IS TOTALLY OCCLUDED BEGINNING AT THE FLOW DIVIDER. A RIGHT-LEFT FEM-FEM BYPASS IS SEEN. THE CONTRALATERAL LIMB WAS POSITIONED DOWN INTO THE LEFT COMMON ILIAC AND IS PATENT. NO ENDOLEAK IS VISIBLE, HOWEVER IT IS POSSIBLE THAT THE AAA IS BEING PRESSURIZED THROUGH THE THROMBUS. EARLIER POST-IMPLANT IMAGES WERE NOT PROVIDED. THE CAUSE OF THE MIGRATION APPEARS MOST LIKELY DUE TO DISEASE PROGRESSION; NECK DILATATION. THE CAUSE OF THE OCCLUSION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701258 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00424556

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR