BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1211495 · Received October 22, 2008

    Report

    Report Number
    2939204-2008-00490
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    February 27, 2008
    Report Date
    October 13, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, 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

    VESSEL DISSECTION. NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH SYMPTOMS OF VERTEBRAL-BASILAR HYPOPERFUSION AND ANGIOGRAPHY REVEALED NEAR TOTAL OCCLUSION OF THE RIGHT BASILAR ARTERY. FOLLOWING SEQUENTIAL ANGIOPLASTY USING TWO PTA DILATION CATHETERS AND THE PLACEMENT OF A STENT, ANGIOGRAPHY REVEALED A DISSECTION IN THE RIGHT VERTEBRALE ARTERY. A SECOND STENT WAS PLACED TO TREAT THE VESSEL DISSECTION AND THERE WERE NO CLINICAL SYMPTOMS ASSOCIATED WITH THE EVENT. THERE WAS SIGNIFICANT IMPROVEMENT IN THE PRESENTING SYMPTOMS AND THE PATIENT IS REPORTED TO BE FUNCTIONALLY INDEPENDENT AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. WS035015 0011315155

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention A WINGSPAN STENTS (BOSTON SCIENTIFIC)| TWO GATEWAY PTA DILATION CATHETER