BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINGSPAN STENT

    MDR report key: 2013320 · Received March 10, 2011

    Report

    Report Number
    2939204-2011-00105
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. DEVICE ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY PROTRUDING THROUGH THE OUTER BODY DISTAL END. THE OUTER BODY WAS STRETCHED ON ITS PROXIMAL SHAFT AT 4.5CM DISTAL TO THE STRAIN RELIEF, AND THE OUTER BODY WAS SLIGHTLY COMPRESSED ON ITS DISTAL SHAFT AT THE STENT LOCATION. THE INNER BODY WAS KINKED AT 5.5CM AND 7.2 CM FROM ITS PROXIMAL END. THE STENT WAS FOUND TO BE WITHIN SPECIFICATIONS. DEVICE FINDINGS ARE INDICATIVE OF STENT NON-DEPLOYMENT AND FRICTION. A DEFINITIVE ROOT CAUSE FOR THE FRICTION AND INABILITY TO FULLY DEPLOY THE STENT CANNOT BE DETERMINED. HOWEVER, IT IS PROBABLE THAT SEVERE TORTUOUSITY RESULTED IN HIGHER DEPLOYMENT FORCE REDUCING THE FORCE TRANSMISSION FROM THE INNER BODY TO THE STENT LIMITING THE PERFORMANCE OF THE DEVICE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT WILL BE ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THE ANATOMY WAS SEVERELY TORTUOUS AND THE PHYSICIAN WAS UNABLE TO FULLY DEPLOY THE STENT ON THE TABLE AFTER IT WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    RESISTANCE WAS ENCOUNTERED DURING AN ATTEMPT TO DEPLOY A STENT IN THE INTERNAL CAROTID ARTERY WITH 85% STENOSIS RESULTING IN THE PARTIAL DEPLOYMENT OF THE STENT. THE PHYSICIAN REMOVED THE ENTIRE DEVICE FROM THE PATIENT AND WAS ABLE TO PLACE A DIFFERENT STENT SUCCESSFULLY. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    RESISTANCE WAS ENCOUNTERED DURING AN ATTEMPT TO DEPLOY A STENT IN THE INTERNAL CAROTID ARTERY WITH 85% STENOSIS RESULTING IN THE PARTIAL DEPLOYMENT OF THE STENT. THE PHYSICIAN REMOVED THE ENTIRE DEVICE FROM THE PATIENT AND WAS ABLE TO PLACE A DIFFERENT STENT SUCCESSFULLY. THERE WAS NO 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 M003WE0450200 13625670

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR