BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CONVERTER STENT GRAFT

    MDR report key: 2100744 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01017
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (PERFORATION, REMOVAL DIFFICULTIES), (SMALL AND SEVERELY CALCIFIED ILIAC ARTERY), (ANOTHER MANUFACTURER'S STENT AND HIGH PRESSURE BALLOON). CONCLUSIONS: (SMALL AND SEVERELY CALCIFIED ILIAC ARTERY), (ANOTHER MANUFACTURER'S STENT AND HIGH PRESSURE BALLOON).

    Description of Event or Problem · 1

    A TALENT CONVERTER STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS A 10 DEGREE ANGULATION AND MODERATE THROMBOSIS IN THE AORTIC NECK. THE RIGHT COMMON ILIAC ARTERY WAS COMPLETELY OCCLUDED. THE LEFT COMMON ILIAC ARTERY WAS 6 MM TO 7 MM IN DIAMETER AND THERE IS SEVERE CALCIFICATION. THE PHYSICIAN ELECTED TO IMPLANT A TALENT CONVERTER AND PERFORM A FEMORAL TO FEMORAL BYPASS, SINCE THE RIGHT ILIAC ARTERY WAS COMPLETELY OCCLUDED. THE TALENT CONVERTER STENT GRAFT WAS INSERTED ON THE LEFT SIDE, HOWEVER, WAS UNABLE TO BE ADVANCED TO THE INTENDED LANDING ZONE. THE DEVICE WAS REMOVED AND THERE WAS A KINK IN THE DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED AN 8MM X 4MM NON-COMPLAINT HIGH PRESSURE BALLOON TO DILATE THE ILIAC LIMB. THE PHYSICIAN REINSERTED THE SAME DEVICE, HOWEVER, THE DEVICE STILL WOULD NOT ADVANCE. THE PHYSICIAN USED A 10MM X 4MM NON-COMPLAINT HIGH PRESSURE BALLOON TO DILATE THE ILIAC LIMB. THE PHYSICIAN REINSERTED THE SAME DEVICE BUT WAS UNABLE TO ADVANCE THE DEVICE TO THE INTENDED LANDING ZONE. PHYSICIAN THEN IMPLANTED A 9MM X 39MM BALLOON EXPANDABLE STENT AND POST DILATED WITH A 12MM X 4MM HIGH PRESSURE BALLOON. THE PHYSICIAN REINSERTED AND ADVANCED THE DEVICE AND DEPLOYED THE STENT GRAFT AT THE LEVEL OF THE LOWEST RENAL ARTERY. IT WAS REPORTED UPON REMOVAL OF THE STENT GRAFT DELIVERY SYSTEM THE ILIAC ARTERY WAS PERFORATED AND WAS PARTIALLY REMOVED WITH THE DELIVERY CATHETER. THE PHYSICIAN DID A RETROPERITONEAL CUT DOWN, CLAMPED THE ARTERY, SEWED IN PTFE GRAFT TO THE TALENT CONVERTER AND PERFORMED THE FEMORAL TO FEMORAL BYPASS. NO ADDITIONAL SEQUELAE WERE REPORTED, AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER STENT GRAFT MIH MEDTRONIC IRELAND NA V00390142

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention