BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT

    MDR report key: 2160771 · Received July 7, 2011

    Report

    Report Number
    2953200-2011-01245
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (ENDOLEAK) RESULTS/CONCLUSIONS: (TOO SHORT DISTAL LANDING ZONE).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM ANEURYSM APPROXIMATELY TEN WEEKS AGO. VESSEL MORPHOLOGY WAS REPORTED AS A DISTAL DIAMETER OF APPROXIMATELY 28 MM; MODERATE CALCIFICATION IN THE DESCENDING THORACIC AORTA; NO ANGULATION. IT WAS REPORTED THAT THE DEVICE WAS DELIBERATELY LANDED SHORT OF THE LUMBAR ARTERIES (BETWEEN T10 AND T11). THE DISTAL SEAL LENGTH, AT IMPLANT, WAS LESS THAN 2 CM. THERE WAS NO ENDOLEAK AFTER IMPLANT. THE PATIENT DOES NOT APPEAR TO HAVE ANY MIGRATION; HOWEVER, A DISTAL TYPE I ENDOLEAK WAS SEEN ON RECENT FILMS. THE PATIENT IS ASYMPTOMATIC. THE PHYSICIAN PLANS TO PLACE AN EXTENSION AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00840146

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention