BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYS

    MDR report key: 1933729 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02575
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS & CONCLUSION: (ANGULATED "S" SHAPED AORTIC ARCH). (DEVICE ADVANCEMENT WAS NOT WATCHED DURING FLUOROSCOPY).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE URGENT ENDOVASCULAR TREATMENT OF A FOCAL TRANSACTION/TEAR WHICH STARTED JUST DISTAL TO THE LSCA. THE NECK LENGTH WAS APPROX 25 MM. THE AORTA HAD MILD THROMBUS AND MILD S-SHAPE ANGULATION STARTING AT THE LCSA. IT WAS REPORTED THAT THE DEVICE ADVANCEMENT WAS NOT WATCHED DURING FLUOROSCOPY. THE DEVICE WAS ADVANCED UP TO THE ARCH AND DEPLOYMENT WAS STARTED AT THE LEFT CAROTID ARTERY. IT WAS REPORTED THE C-BAR WAS CATCHING THE S-SHAPED BEND OF THE ANATOMY AND WAS FAVORING THE INNER/ANTERIOR AORTIC CURVE. THE DEVICE WAS NOT ADVANCED OR TORQUED DURING THE ACTUAL STENT GRAFT DEPLOYMENT. THE PHYSICIAN ATTEMPTED NORMAL RE-POSITIONING OF THE C-BAR BEFORE DEPLOYMENT BY ROTATING THE DELIVERY SYS AND MOVING IT BACK AND FORTH TO RELEASE THE STORED ENERGY. AS THIS WAS UNSUCCESSFUL, THE PHYSICIAN PULLED THE DEVICE DOWN INTO THE DESCENDING AORTA AND AGAIN TRIED TO ROTATE THE DELIVERY SYSTEM TO ALIGN THE C-BAR, THIS ALSO DID NOT WORK. THE GRAFT WAS DEPLOYED AT UNINTENDED LOCATION AND THERE WAS A PROXIMAL TYPE 1 ENDOLEAK. A SECOND TALENT CAPTIVIA GRAFT WAS PLACED PROXIMALLY WITH CAREFUL DEPLOYMENT TO RESOLVE THE ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYS MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00540346

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention