BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 2210570 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01415
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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). EVAL, RESULTS: ENDOLEAK. RESULTS/CONCLUSIONS: (UNK CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A LEAKING PSEUDOANEURYSM, WHICH HAD AN EXPANDING HEMATOMA. THE THORACIC AORTA HAD APPROXIMATELY 5-6 MM SIZE DIFFERENCE FROM THE FLOW LUMEN TO THE OUTER MEASUREMENT OF THE HEMATOMA. THE ILIAC VESSELS WERE STRAIGHT AND UNREMARKABLE. IT WAS REPORTED TWO TALENT CAPTIVIA STENT GRAFTS, A 38X38X199 (MFR REPORT# 2953200-2011-01415) AND A 36X36X199 (MFR REPORT # 2953200-2011-01416), WERE IMPLANTED FROM THE LEFT SUBCLAVIAN ARTERY DOWN TO 2 CM ABOVE THE CELIAC ARTERY. ON THE FINAL ANGIOGRAM, NO ENDOLEAK WAS EVIDENT; HOWEVER, AT A FOLLOW-UP CT APPROXIMATELY 2 WEEKS POST-PROCEDURE, A DISTAL TYPE I ENDOLEAK WAS SEEN. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A DISTAL EXTENSION, WHICH LANDED RIGHT AT THE CELIAC ARTERY. THE FINAL ANGIOGRAM SHOWED THE CELIAC FILLING AND THAT THE ENDOLEAK WAS RESOLVED. HOWEVER, SEVERAL DAYS AFTER, A CT WAS PERFORMED AND DEMONSTRATED AN UNK ENDOLEAK, WHICH MIGHT HAVE BEEN A TYPE II ENDOLEAK OR A JUNCTIONAL TYPE III ENDOLEAK BETWEEN THE TWO INITIAL STENT GRAFTS. THE PHYSICIAN DECIDED NOT TO PERFORM ANY INTERVENTION BUT WILL MONITOR THE PT. NO ADDITIONAL 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 SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00565887

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention