BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT

    MDR report key: 1911065 · Received November 24, 2010

    Report

    Report Number
    2953200-2010-02340
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: ARTERIAL TRAUMA/DISSECTION/PERFORATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE NOT AVAILABLE. IT WAS REPORTED THAT THE PT PRESENTED EMERGENTLY, THE PHYSICIAN INSERTED A 26X22 STENT GRAFT INTO THE PT, AND STARTED TO DEPLOY THE STENT GRAFT FOR IMPLANTATION. AS THE PHYSICIAN THOUGHT THAT THE DEPLOYMENT OF STENT GRAFT WAS COMPLETED, HE PULLED THE DELIVERY SYSTEM TO RETRACT THE TAPERED TIP INTO THE OUTER SHEATH. THEN THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM FROM THE ACCESS VESSEL. AT THE FINAL WITHDRAWAL OF THE DELIVERY SYSTEM, HE NOTICED THE STENT GRAFT ALSO WAS BEING WITHDRAWN AS THE GRAFT WAS CATCHING ON THE GAP BETWEEN THE TAPERED TIP AND THE OUTER SHEATH OF THE DELIVERY SYSTEM. DURING REMOVAL, THE ACCESS VESSEL OF THE ILIAC ARTERY WAS DAMAGED AND WAS REPLACED WITH A SYNTHETIC GRAFT. THEN, THE PHYSICIAN RE-ASSEMBLED THE WITHDRAWN STENT GRAFT AND THE DELIVERY CATHETER, AND HE USED IT AGAIN FOR THE TEVAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00314817

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention