BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1894093 · Received November 9, 2010

    Report

    Report Number
    2134265-2010-05122
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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 LEFT COMMON ILIAC STENTING TREATMENT PROCEDURE, A PATIENT EXPERIENCED PAIN UPON DEPLOYMENT. THE UNSPECIFIED TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. A 14X60/9FR WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM WAS SELECTED. UPON DEPLOYMENT THE PATIENT EXPERIENCED PAIN AND CONTINUES TO EXPERIENCE PAIN POST PROCEDURE AT THE 'IMPLANT' SITE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965403120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other