BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1172580 · Received September 19, 2008

    Report

    Report Number
    2953200-2008-00831
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (BALLOON), (DEVICE DISCARDED UNABLE TO EVALUATE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY IS COMMON ILIAC AND EXTERNAL ILIAC ARTERIES HAVE MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED. IT WAS REPORTED THAT UPON DEPLOYMENT OF THE MAIN BODY, THE PHYSICIAN INFLATED THE BALLOON WHICH WAS LOCATED INSIDE THE DELIVERY SYSTEM WITH A 10CC SYRINGE, 1/3 STRENGTH. THE PHYSICIAN INJECTED APPROX 5CC BEFORE ATTEMPTING TO ASPIRATE THE FLUID AND REMOVE THE DELIVERY SYSTEM. WHEN THE PHYSICIAN ASPIRATED THROUGH THE SYRINGE, THE BALLOON REMAINED FULLY INFLATED. HE REPLACED THE 10 CC SYRINGE WITH AN EMPTY 20 CC SYRINGE AND TRIED TO ASPIRATE THE FLUID FROM THE BALLOON. THE BALLOON REMAINED FULLY INFLATED. THE PHYSICIAN WAS ABLE TO DEFLATE THE BALLOON. ONE PERSON FULLY ASPIRATED THE SYRINGE AND HELD THE SYRINGE IN THAT POSITION. MEANWHILE, THE PHYSICIAN TWISTED THE SYRINGE OFF OF THE SIDE PORT OF THE BALLOON CATHETER. WHEN THIS BECAME UNSUCCESSFUL, THE PHYSICIAN REMOVED THE CONNECTOR TUBE AS A TROUBLE SHOOTING EFFORT WITH THE ASSUMPTION THAT IT WAS NOT FUNCTIONING. THE PHYSICIAN WAS ABLE TO DEFLATE THE BALLOON WITH THIS TECHNIQUE. THE DEVICE WAS DISCARDED BY THE USER FACILITY. THERE ARE NO FURTHER CLINICAL SEQUELAES REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00123311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK