BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINGSPAN STENT

    MDR report key: 1972053 · Received January 27, 2011

    Report

    Report Number
    2939204-2011-00034
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INSPECTION OF THE RETURNED DEVICE NOTED THAT A QUARTER OF THE STENT WAS PARTIALLY PROTRUDING THROUGH THE OUTER BODY DISTAL TIP AND THE INNER BODY BUMPER MARKER WAS BUTTED AGAINST THE STENT PROXIMAL MARKERS. THE INNER BODY WAS ADVANCED AND THE STENT DEPLOYED ON THE TABLE. NO ANOMALIES WERE NOTED TO THE DEVICE. BASED ON THE INVESTIGATION THE PARTIAL STENT DEPLOYMENT APPEARS TO BE DUE TO IT BEING PUSHED OUT BY THE INNER BODY. FROM THE INVESTIGATION AND INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE ADVANCING THE DEVICE THROUGH THE MID SECTION OF THE GUIDE CATHETER SO THE DEVICE WAS REMOVED. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT QUARTER OF THE STENT HAD DEPLOYED FROM THE DELIVERY SYSTEM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE ADVANCING THE DEVICE THROUGH THE MID SECTION OF THE GUIDE CATHETER SO THE DEVICE WAS REMOVED. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT QUARTER OF THE STENT HAD DEPLOYED FROM THE DELIVERY SYSTEM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WE0250090 13891823

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 6F GUIDE CATHETER, MODEL UNKNOWN (J & J)