BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT THORACIC STENT GRAFT

    MDR report key: 2191177 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01358
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    February 7, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS AND CONCLUSIONS: (EXPLANT ANALYSIS CANNOT BE PERFORMED DUE TO INFECTED DEVICE).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON AN UNK DATE. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFT WAS EXPLANTED DUE TO AN INFECTION OF THE GRAFT. NO FURTHER INFO LEADING TO THE EXPLANT OR CLINICAL SEQUELAE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT THORACIC STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention