BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA?

    MDR report key: 3200127 · Received July 1, 2013

    Report

    Report Number
    2134265-2013-04413
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT BECAME SHORTENED. THE 6X201X75 INNOVA STENT WAS INTRODUCED TO TREAT AN UNSPECIFIED TARGET LESION. DURING THE PROCEDURE, THE STENT BECAME SHORTENED BY ABOUT 10 CM AND A DIFFERENT SECOND STENT WAS IMPLANTED TO FINISH THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297745 INNOVA? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939180062070 0016004450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention