BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 3.5 X 15MM

    MDR report key: 3173375 · Received June 17, 2013

    Report

    Report Number
    3008853977-2013-00189
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT COMPLICATIONS ARE NOTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THE PATIENT COMPLICATIONS. RISK ANALYSIS IDENTIFIED SEVERAL POTENTIAL CAUSES FOR THE REPORTED STENT DISLODGED/MIGRATED, HOWEVER, REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE. AS A RESULT, A CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THE REPORTED STENT DISLODGED/MIGRATED ISSUE.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PHYSICIAN DEPLOYED A WINGSPAN SYSTEM IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. HOWEVER, THE STENT MIGRATED FROM THE M1 TO THE M2 SEGMENT AFTER DEPLOYMENT. IT WAS MENTIONED THAT THE GUIDEWIRE ALSO MOVED INTO THE DISTAL PORTION WITH THE STENT MIGRATION, AND THE GUIDEWIRE MAY HAVE MADE ¿SOME DAMAGE¿ TO THE SMALL VESSELS. THE PATIENT IS CURRENTLY IN THE HOSPITAL AND IS REPORTED NOT BE IN GOOD CONDITION. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING A PROCEDURE THE PHYSICIAN DEPLOYED A WINGSPAN SYSTEM IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. HOWEVER THE STENT MIGRATED FROM THE M1 TO THE M2 SEGMENT AFTER DEPLOYMENT. IT WAS MENTIONED THAT THE GUIDEWIRE ALSO MOVED INTO THE DISTAL PORTION WITH THE STENT MIGRATION, AND THE GUIDEWIRE MAY HAVE MADE ¿SOME DAMAGE¿ TO THE SMALL VESSELS. THE PATIENT IS CURRENTLY IN THE HOSPITAL AND IS REPORTED NOT BE IN GOOD CONDITION. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273843 F/G WINGSPAN STENT SYSTEM 3.5 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRANSEND GUIDEWIRE (STRYKER)