BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1891223 · Received November 4, 2010

    Report

    Report Number
    1016427-2010-00135
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    June 25, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 1016427-2010-00134 AND 1016427-2010-00135.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY: THE TARGET LESION WAS A 99% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. A 5MM ANGIOGUARD DEVICE WAS ADVANCED BEYOND THE TARGET AND WAS DEPLOYED WITHOUT DIFFICULTY. A 6.0 X 30MM PRECISE STENT WAS DEPLOYED SUCCESSFULLY. FOLLOWING STENT DEPLOYMENT, THE PATIENT EXPERIENCED APHASIA, HEMIPARESIS ON THE RIGHT. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS OBSERVED WITHIN THE FILTER BASKET. THE EVENT ONSET WAS SUDDEN AND RECOVERY WAS PARTIAL WITH MAJOR RESIDUAL. DIAGNOSIS WAS ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309393 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70909511

    Patients

    Seq Age Sex Outcome Treatment
    1