BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 3.5 X 15MM

    MDR report key: 2892129 · Received January 2, 2013

    Report

    Report Number
    3008853977-2013-00001
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATION NONCONFORMANCE. THERE IS ALSO NO INDICATION THAT THE WINGSPAN DEVICE MALFUNCTIONED. THE REPORTED THROMBOSIS IS A KNOWN AND ANTICIPATED COMPLICATION ASSOCIATED TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENT STENT ASSISTED ANGIOPLASTY PROCEDURE OF THE MIDDLE CEREBRA ARTERY (MCA), THROMBUS FORMATION WAS OBSERVED POST STENT DEPLOYMENT. THE PHYSICIAN ADMINISTERED INTEGRILIN (DOSE UNKNOWN) WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PROCEDURE RESULTED IN RE-ESTABLISHMENT OF GOOD FLOW IN THE MCA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENT STENT ASSISTED ANGIOPLASTY PROCEDURE OF THE MIDDLE CEREBRA ARTERY (MCA), THROMBUS FORMATION WAS OBSERVED POST STENT DEPLOYMENT. THE PHYSICIAN ADMINISTERED INTEGRILLN (DOSE UNKNOWN) WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PROCEDURE RESULTED IN RE-ESTABLISHMENT OF GOOD FLOW IN THE MCA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENT STENT ASSISTED ANGIOPLASTY PROCEDURE OF THE MIDDLE CEREBRA ARTERY (MCA), THROMBUS FORMATION WAS OBSERVED POST STENT DEPLOYMENT. THE PHYSICIAN ADMINISTERED INTEGRILLN (DOSE UNKNOWN) WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PROCEDURE RESULTED IN RE-ESTABLISHMENT OF GOOD FLOW IN THE MCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637 F/G WINGSPAN STENT SYSTEM 3.5 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF N/A 14914723

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention