BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V12 COVERED STENT

    MDR report key: 4122253 · Received September 18, 2014

    Report

    Report Number
    1219977-2014-00312
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THE RETURN OF THE DEVICE FOR INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE STENT SLIPPED OFF THE BALLOON AS IT WENT THROUGH THE INTRODUCER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578878 V12 COVERED STENT COVERED STENT MAF ATRIUM MEDICAL CORP. 85337 212188

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention