BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1161261 · Received September 12, 2008

    Report

    Report Number
    1016427-2008-00241
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 21, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT# 9616099-2008-02222. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT RECEIVED A PRECISE STENT IN THE CAROTID. AN ANGIOGUARD HAD BEEN SUCCESSFULLY DEPLOYED. POST STENT DEPLOYMENT THE PT HAD A SUDDEN NEUROLOGICAL DEFICIT REPORTED AS APHASIA AND RIGHT HEMIPARESIS WHICH WAS DIAGNOSED AS A TRANSIENT ISCHEMIC ATTACK. THE ANGIOGUARD WAS STILL IN PLACE WHEN THE EVENTS BEGAN TO OCCUR. THE PT HAD PARTIAL RECOVERY WITH MINOR RESIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70608505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening CLOPIDOGREL| ASPIRIN