BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVA STENT GRAFT SYSTEM

    MDR report key: 2231453 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01431
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS - (STENT GRAFT MISREPLACEMENT), (PRE-OPERATIVE TRANSECTION), (DEVICE WAS USED TO TREAT A TRANSECTION). CONCLUSION - (PRE-OPERATIVE TRANSECTION), (DEVICE WAS USED TO TREAT A TRANSECTION).

    Description of Event or Problem · 1

    A TALENT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC TRANSECTION. THE AORTIC ARCH HAD AN ACUTE BEND AND WAS DESCRIBED AS A TYPE 2 ARCH. IT WAS REPORTED THAT THE PROXIMAL MAIN TALENT CAPTIVA DEVICE WAS INSERTED W/O PROBLEM; HOWEVER, THE DEPLOYMENT HANDLE HAD TO BE ROTATED 15 OR MORE TIMES BEFORE THE STENT GRAFT STARTED TO DEPLOY, AND THEN DURING DEPLOYMENT, THE STENT GRAFT JUMPED BACKWARDS APPROXIMATELY 15MM. THE BLOOD PRESSURE WAS KEPT LOW DURING THE DEPLOYMENT. IT WAS ALSO NOTED THAT THERE WAS A KINK OF THE OUTER CATHETER SHAFT; HOWEVER, IT IS UNKNOWN WHEN THE KINK HAD OCCURRED. THE PHYSICIAN COMMENTED THAT THE KINK OF THE DELIVERY SYSTEM WAS WHAT HAD CAUSED THE DEPLOYMENT DIFFICULTIES; THE KINK MAY HAVE STORED TOO MUCH ENERGY WITHIN THE DELIVERY SYSTEM AND CONSEQUENTLY CAUSED THE STENT GRAFT TO EVENTUALLY JUMP[ BACKWARDS. INITIALLY, THE PHYSICIAN ELECTED NOT TO INTERVENE ANY FURTHER; HOWEVER, 2 HOURS LATER, IT WAS NOTED THAT THE TRANSECTION WAS EXTENDING DISTALLY BEYOND THE STENT GRAFT. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A TALENT THORACIC STENT GRAFT DISTALLY AND ALSO PLACING A 36X36X199 TALENT CAPTIVA PROXIMALLY TO RELINE THE INITIAL TALENT CAPTIVA STENT GRAFT AND COMPENSATE FOR ITS 15 MM OF DISTAL MOVEMENT. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00550141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR