BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT SYTEM

    MDR report key: 1363031 · Received April 13, 2009

    Report

    Report Number
    2939204-2009-00320
    Event Type
    Death
    Date Received
    April 13, 2009
    Report Date
    March 23, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE IS UNKNOWN, ALL PATIENTS IN THE REGISTRY WERE TREATED BETWEEN 2005 AND 2006. UNKNOWN, AS THE UPN AND BATCH NUMBERS WERE NOT DISCLOSED. EXACT DATE IS UNKNOWN, ALL PATIENTS IN THE REGISTRY WERE TREATED BETWEEN 2005 AND 2006. OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. REPORT SOURCE: NEUROLOGY. 2008; 70(17): 1518-24 AND NEUROLOGY. 2009. [EPUB AHEAD OF PRINT].

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED IN AN ARTICLE FROM AN NATIONAL INSTITUTE OF HEALTH REGISTRY TO INVESTIGATE THE SUCCESS OF TREATING PATIENTS WITH 50% TO 99% STENOSIS WITH ANGIOPLASTY AND A SINGLE INTRACRANIAL STENT. THIS REPORT IS FOR A PATIENT, WITH 70% TO 99% STENOSIS, WHO SUFFERED A NON-FATAL ISCHEMIC STROKE IN AN OUT OF THE STENTED REGION WITHIN TWENTY FOUR HOURS OF THE PROCEDURE, CONSIDERED TO BE PERI-PROCEDURE BY THE STUDY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYTEM NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GATEWAY PTA BALLOON CATHETER:| (MODEL UNK