BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1930731 · Received December 16, 2010

    Report

    Report Number
    2134265-2010-05446
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: CORRECTION; IT WAS ORIGINALLY REPORTED THAT THE STENT HAD TO BE SNARED; HOWEVER, IT WAS FURTHER REPORTED THAT THE STENT WAS ABLE TO BE RECONSTRAINED AND REMOVED WITHOUT ISSUE. THE SNARE WAS USED IN THE PROCEDURE FOR ANOTHER UNSPECIFIED REASON. (B)(4).

    Additional Manufacturer Narrative · 1

    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 FURTHER REPORTED THAT ANGIOPLASTY WAS PERFORMED AT AN UNSPECIFIED TIME DURING THE PROCEDURE WITH A 12MM BALLOON. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO DEPLOY THE 24X35/11FR WALLSTENT ENDOPROSTHESIS. THE STENT HAD EXPANDED TO LESS THAN 20%. IT WAS ORIGINALLY REPORTED THAT THE STENT HAD TO BE SNARED; HOWEVER, IT WAS FURTHER REPORTED THAT THE STENT WAS ABLE TO BE RECONSTRAINED AND REMOVED WITHOUT ISSUE. THE SNARE WAS USED IN THE PROCEDURE FOR ANOTHER UNSPECIFIED REASON. THE PROCEDURE WAS COMPLETED WITH A 24X35 WALLSTENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DID NOT FULLY DEPLOY. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. THE 24X35/11FR WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO THE LESION, BUT WOULD NOT FULLY EXPAND. A SNARING DEVICE WAS USED TO REMOVE THE STENT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED 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 H965405100 13091529

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention