BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT UNKNOWN STENT GRAFT- OUS

    MDR report key: 2033550 · Received March 24, 2011

    Report

    Report Number
    2953200-2011-00691
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: LOT NUMBER, IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. CONCLUSIONS: REMOVAL OF IMPLANT, OTHER LOT NUMBER, IMPLANT AND EXPLANT DATES WERE NOT PROVIDED.

    Description of Event or Problem · 1

    A PHYSICIAN PRESENTED OBSERVATIONS WHICH WERE OBTAINED BY REVIEWING STENT GRAFTS. THE PHYSICIAN PLANS TO PUBLISH A PAPER WHICH INCLUDES THESE OBSERVATIONS. THE STENT GRAFTS WHICH WERE INVESTIGATED WERE FIVE TALENT STENT GRAFTS OF WHICH ONE SHOWED SIGNS OF STENT GRAFT FRACTURE (REFERENCE FILE 2953200-2011-00690) AND THE REMAINING FOUR SHOWED SIGNS OF STENT GRAFT HOLES (REFERENCE FILES 2953200-2011-00691, 2953200-2011-00692, 2953200-2011-00693 AND 2953200-2011-00694). MEDTRONIC WAS NOT ABLE TO OBTAIN DETAILED CASE OBSERVATION SUCH AS ANATOMY, REASON FOR EXPLANT AND PT STATUS. THE ACTUAL STENT GRAFTS AND ASSOCIATED DELIVERY SYSTEMS WERE NOT RETURNED TO MEDTRONIC. NO FURTHER INFORMATION WAS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT UNKNOWN STENT GRAFT- OUS NONE MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention