BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 3.0 X 20MM

    MDR report key: 4252211 · Received November 14, 2014

    Report

    Report Number
    3008853977-2014-00361
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINS IMPLANTED; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BECAUSE THE REPORTED EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITH THE DIRECTIONS FOR USE AND/OR DEVICE LABELING, A CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A BALLOON PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) CASE FOR A CHRONIC STAGE M1 STENOSIS (OF THE MIDDLE CEREBRAL ARTERY), A BALLOON CATHETER WAS USED, BUT RESTENOSIS WAS CONFIRMED AFTER A FEW MINUTES. AFTER PLACEMENT OF A STENT (SUBJECT DEVICE), ANGIOGRAPHY INDICATED IN-STENT THROMBOSIS. BALLOON PTA WAS PERFORMED WITH A LARGER BALLOON CATHETER TO RESOLVE FLOW. THERE WERE NO PATIENT COMPLICATIONS OR INJURY REPORTED DUE TO THIS EVENT. IN THE PHYSICIAN¿S OPINION, BECAUSE IT IS POSSIBLE THAT ANTIPLATELET MEDICATIONS DID NOT WORK EFFECTIVELY FOR THE PATIENT, IT APPEARS THAT THE IN-STENT THROMBOSIS OCCURRED FROM THE THROMBUS CAUSED BY THE INITIAL BALLOON PTA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A BALLOON PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) CASE FOR A CHRONIC STAGE M1 STENOSIS (OF THE MIDDLE CEREBRAL ARTERY), A BALLOON CATHETER WAS USED, BUT RESTENOSIS WAS CONFIRMED AFTER A FEW MINUTES. AFTER PLACEMENT OF A STENT (SUBJECT DEVICE), ANGIOGRAPHY INDICATED IN-STENT THROMBOSIS. BALLOON PTA WAS PERFORMED WITH A LARGER BALLOON CATHETER TO RESOLVE FLOW. THERE WERE NO PATIENT COMPLICATIONS OR INJURY REPORTED DUE TO THIS EVENT. IN THE PHYSICIAN¿S OPINION, BECAUSE IT IS POSSIBLE THAT ANTIPLATELET MEDICATIONS DID NOT WORK EFFECTIVELY FOR THE PATIENT, IT APPEARS THAT THE IN-STENT THROMBOSIS OCCURRED FROM THE THROMBUS CAUSED BY THE INITIAL BALLOON PTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738514 F/G WINGSPAN STENT SYSTEM 3.0 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF 16490009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GATEWAY (BOSTON SCIENTIFIC)