BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 2211984 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01404
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVAL: (DELIVERY CATHETER BREAKAGE).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT WAS SELECTED FOR USE IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE DELIVERY SYS HANDLE WAS FOUND BROKEN/DETACHED WHEN IT WAS REMOVED FROM THE PACKAGING. THE PACKAGING WAS COMPLETELY INTACT AND DID NOT HAVE ANY DAMAGE. THE DELIVERY SYS ITSELF DID NOT HAVE ANY OTHER DAMAGE. THE PHYSICIAN ELECTED TO NOT USE THE DEVICE; ANOTHER DELIVERY SYS WAS USED TO COMPLETE THE CASE WITHOUT ISSUES. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DEVICE HAS BEEN RECEIVED BY MEDTRONIC, AND THE ANALYSIS HAS BEEN COMPLETED. THE DEVICE HAD SOME RESIDUE OF BLOOD. THE STENT GRAFT WAS STILL LOADED IN PLACE. THE RELEASE/RECAPTURE HANDLE WAS NOTED TO BE SPLIT APART IN THE TRY. WHEN THE DEVICE WAS TAKEN OFF THE TRAY, THE RELEASE/RECAPTURE HANDLE WAS COMPLETELY SEPARATED. DURING EVAL, THE TWO HALVES OF THE RELEASE/RECAPTURE HANDLE WERE EXAMINED, AND THE FLAPS HAD EVIDENT STRESS MARKS. THE HANDLE WAS REASSEMBLED ON THE BACKEND OF THE DEVICE AND WAS ABLE TO LOCK AND RELEASE BUT WITH SOME ABNORMAL RESISTANCE. THE DEVICE WAS SEATED BACK IN THE TRAY, AND THE RELEASE/RECAPTURE HANDLE HALVES SEPARATED EASILY WHEN THE DEVICE WAS REMOVED FROM THE TRAY. THE COMPLAINT WAS CONFIRMED; HOWEVER, THE EVAL OF THE RETURNED DEVICE COULD NOT CONCLUSIVELY DETERMINE WHAT HAD CAUSED THE BACKEND HANDLE TO SEPARATE AND COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00899467

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK