BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1211590 · Received October 23, 2008

    Report

    Report Number
    2939204-2008-00499
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF ANY DEVICE MALFUNCTION OR NONCONFORMANCE THAT CONTRIBUTED TO THE EVENT. THE DEVICE IS UNAVAILABLE FOR EVALUATION. THROMBOSIS IS AN INHERENT RISK WITH ANY INTRODUCTION OF A FOREIGN BODY INTO THE VASCULATURE, SUCH AS NEUROVASCULAR STENT IMPLANTATION. PROPER ADJUNCTIVE MEDICAL ANTI-PLATELET THERAPY IS NECESSARY TO PREVENT THROMBOSIS. THE ROOT CAUSE OF STENT THROMBOSIS CANNOT BE DEFINITIVELY DETERMINED. IDENTIFIED POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO IMPROPER ANTIPLATELET THERAPY, IMPROPER DEVICE SELECTION, OR IMPROPER STENT PLACEMENT. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT THIS DEVICE NET ALL REQUIRED SPECIFICATIONS. THE INTENDED USE FOR THE DEVICE IS TREATMENT. BASED ON THE INVESTIGATION AND INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE RELEASED DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE LABELING WAS CONDUCTED AND THE FOLLOWING HAS BEEN DETERMINED: THE DIRECTIONS FOR USE (DFU) INCLUDES LANGUAGE REGARDING THE REPORTED ISSUE (THROMBOSIS). THERE IS NO INDICATION THAT THE PHYSICIAN DID NOT USE THE DEVICE ACCORDING TO THE DFU. AS A RESULT, THERE IS NO INDICATION FROM THE INFORMATION PROVIDED THAT MISUSE CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS ALSO NO INDICATION THAT THE STENT MALFUNCTIONED. THROMBOSIS IS AN ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DEVICE DFU. AS A RESULT, A ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH LEFT SIDED WEAKNESS AND SLURRED SPEECH. AN ANGIOPLASTY WAS PERFORMED BUT WAS NOT EFFECTIVE IN RESTORING CIRCULATION. THE PHYSICIAN THEN PLACED A STENT (SUBJECT DEVICE) IN THE DISTAL RIGHT MIDDLE CEREBRAL ARTERY (MCA) WHICH RESULTED IN SIGNIFICANT IMPROVEMENT OF FLOW. HOWEVER, DEVELOPMENT OF A THROMBUS AT THE MID-PORTION OF THE STENT OCCURRED; THE CLOT WAS "ANGIOPLASTIED" USING A BALLOON CATHETER AND A UNIT OF RETAVACE WAS ADMINISTERED. FINAL ANGIOGRAPHIC RESULTS REVEALED COMPLETE RESTORATION OF CIRCULATION TO THE HEMISPHERE. IT WAS REPORTED THAT THE PATIENT HAS BEEN TRANSFERRED TO AN INPATIENT REHABILITATION FACILITY FOR CONTINUED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) INTRACRANIAL STENT NJE BOSTON SCIENTIFIC CORP. WS035020 9738415

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention TWO TRANSEND GUDIEWIRE| GATEWAY BALLOON (BOSTON SCIENTIFIC)