BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT

    MDR report key: 2100743 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01018
    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
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (CONVERSION TO OPEN SURGERY, INACCURATE PLACEMENT, OCCLUSION), (PENDING DEVICE EVALUATION). CONCLUSION: (PENDING DEVICE EVALUATION).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THERE WAS THROMBOSIS IN THE SAC. THE ASCENDING AORTA WAS 41-42 MM IN DIAMETER, THEN NARROWED TO 27-28 MM IN DIAMETER FOR ABOUT 2.5 CM IN LENGTH BETWEEN THE LCCA AND LSCA. THE DISTAL AORTA WAS 31-32 MM IN DIAMETER, AND THERE WAS A LONG DISTAL LANDING ZONE. THE AORTA HAD UNREMARKABLE TORTUOSITY. ACCESS VESSELS WERE 7.5 MM IN DIAMETER WITHOUT CALCIFICATION. THE PT HAD A LCCA-LSCA BYPASS PRIOR TO THE TEVAR. ON TALENT CAPTIVIA DEVICE WAS INSERTED TO THE INTENDED LANDING ZONE, AND WHEN THE FIRST STENT RING WAS ALMOST DEPLOYED, THE STENT GRAFT MOVED ABOUT 2-3 CM DISTALLY FROM THE SUBCLAVIAN. THE PROPER GRAY TO BLUE HANDLE UNITING HAD BEEN FOLLOWED AFTER THE TIP CAPTURE MECHANISM HAD BEEN RELEASED. THERE WAS NO OBVIOUS PROXIMAL ENDOLEAK. AN ATTEMPT WAS MADE TO PUSH THE DEVICE FORWARD SLIGHTLY TO THE INTENDED LANDING ZONE, WHICH WAS PROXIMAL TO THE LSCA. AS THE STENT GRAFT WAS STILL FURTHER DISTAL THAN INTENDED, ANOTHER STENT GRAFT WAS SELECTED TO BE PLACED MORE PROXIMALLY. HOWEVER, THE FIRST STENT GRAFT HAD SLIPPED ALL THE WAY PAST THE CELIAC IN THE ABDOMEN AND COVERED THE RENALS. THE DELIVERY SYSTEM MIGHT HAVE GRABBED ON PART OF THE STENT GRAFT AND PULLED THE GRAFT DISTALLY INTO THE ABDOMEN. THE PT WAS THEN SURGICALLY-CONVERTED WITHOUT ISSUES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DEVICE HAS BEEN RETURNED AND THE ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT MIH MEDTRONIC IRELAND NA V00568043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention