BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1905381 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02268
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    April 13, 2010
    Report Date
    July 21, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P07007
    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), (CAUSE OF DISSECTION CAN NOT BE DETERMINED). EVAL, CONCLUSIONS: (CAUSE OF DISSECTION CAN NOT BE DETERMINED).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.0 CM X 5.5 CM SACCULAR THORACIC AORTIC ANEURYSM AT ZONE 4 APPROX 7 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS MODERATE CALCIFICATION IN THE ILIAC ARTERY. THE TWO TALENT THORACIC STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THE DELIVERY CATHETERS WERE REMOVED WITHOUT ISSUE. IT WAS REPORTED AFTER THE FINAL ANGIOGRAM, THERE WAS A DISSECTION IN THE ILIAC VESSEL. THE PHYSICIAN IMPLANTED AN UNK STENT WHICH RESOLVED THE DISSECTION. (MFG#2953200-2010-02267). AT THE THREE MONTH F/U, THE STENT GRAFT WAS PATENT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE INVESTIGATOR ASSESSED THAT THE ANGIOGRAPHY REVEALED THE LOCATION OF THE DISSECTION OBSERVED ON TO BE IN THE RIGHT EXTERNAL ILIAC ARTERY. THE RIGHT EXTERNAL ILIAC ARTERY WAS THE ACCESS VESSEL USED DURING IMPLANT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR NA V00143340Y

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention