BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC - XCELERANT

    MDR report key: 1822557 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01655
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    April 26, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: HEMATOMA, DISEASED VESSELS; LACK OF INFORMATION, UNK CAUSE OF HEMATOMA. CONCLUSIONS: DISEASED VESSELS; LACK OF INFORMATION, UNK CAUSE OF HEMATOMA.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM THORACIC ANEURYSM IN ZONES 3 AND 4 WITH A MAXIMUM DIAMETER OF 65 MM AND A LENGTH OF 100 MM. THE THORACIC AORTIC HAD NO THROMBUS. THE ACCESS ARTERIES HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE COMMON ILIAC VEIN WAS DENSELY ADHERED TO THE COMMON ILIAC ARTERY DUE TO LIKELY ATHEROSCLEROTIC INFLAMMATION PRIOR TO STENT GRAFT IMPLANTATION. IT WAS REPORTED THAT AN INVESTIGATIONAL THORACIC STENT GRAFT WAS SUCCESSFULLY DEPLOYED, FOLLOWED BY A TALENT XCELERANT STENT GRAFT, AND MODELED WITH A RELIANT BALLOON. COMPLETION ANGIOGRAPHY REVEALED GOOD APPOSITION OF THE STENT GRAFT, NO EVIDENCE OF AN ENDOLEAK, AND A PT CELIAC ARTERY. IT WAS REPORTED THAT THE FOLLOWING DAY, THE CT SCAN REVEALED A RETROPERITONEAL HEMATOMA EXTENDING TO THE PELVIS. THE HEMATOMA WAS EVACUATED SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC - XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00200501

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention