BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA SELF-EXPANDING STENT SYSTEM

    MDR report key: 3112477 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03181
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. EVENT DATE: (B)(6). 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, GUIDE WIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. UTILIZING AN IPSILATERAL APPROACH, AN UNSPECIFIED INNOVA STENT SYSTEM WAS ADVANCED OVER A NON BSC GUIDE WIRE. THE STENT WAS DEPLOYED WITHOUT ISSUE. HOWEVER, WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM, THE SHAFT OF THE INNOVA DEVICE WAS STUCK ON THE GUIDE WIRE. THE DEVICES WERE REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212736 INNOVA SELF-EXPANDING STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK695

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK TEFLON GUIDE WIRE