BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1760604 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01305
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: MODERATE TO SEVERE TORTUOSITY AND MODERATE CALCIFICATION; AORTIC NECK ANGULATION. EVALUATION CONCLUSION: MODERATE TO SEVERE TORTUOSITY AND MODERATE CALCIFICATION; AORTIC NECK ANGULATION. INCOMPLETE DEPLOYMENT OF THE STENT GRAFT.

    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 WAS REPORTED AS MODERATE TO SEVERE TORTUOSITY AND MODERATE CALCIFICATION. THE AORTIC NECK WAS 25 MM IN LENGTH, 29 MM IN DIAMETER, AND ANGULATED 60 DEGREES. IT WAS REPORTED THAT THE TALENT BIFURCATED STENT GRAFT WAS BEING DEPLOYED FROM THE RIGHT SIDE; HOWEVER, THE PHYSICIAN DID NOT COMPLETELY DEPLOY THE STENT GRAFT, AND THEREFORE UPON DEVICE REMOVAL, THE TIP OF THE DELIVERY SYSTEM WAS CAUGHT ON THE STENT GRAFT MATERIAL. AS A RESULT, THE STENT GRAFT WAS PULLED DOWN TO THE DISTAL AORTIC BIFURCATION, AND THE CONTRALATERAL STUB LEG BECAME KINKED, WITH ITS OPENING FACING UPWARD. THE PHYSICIAN ELECTED TO INTERVENE BY CONVERTING THE PATIENT TO AN AORTO-UNI-ILIAC (AUI). A TALENT CONVERTER (MFR # 2953200-2010-01304) WAS INSERTED INTO THE PATIENT; HOWEVER, THE DEVICE WAS UNABLE TO BE ADVANCED, BECAUSE THE DEVICE KINKED DUE TO THE TORTUOUS ANATOMY. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS DISCARDED BY THE USER FACILITY. THE PHYSICIAN THEN SUCCESSFULLY PLACED A 36 MM TALENT CONVERTER ON THE LEFT SIDE, FOLLOWED BY PLACING A TALENT OCCLUDER ON THE RIGHT SIDE AND PERFORMING A FEMORAL-FEMORAL BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00453249

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention