BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1180171 · Received September 29, 2008

    Report

    Report Number
    1016427-2008-00251
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-02357. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A 95% LESION IN THE MID INTERNAL CAROTID ARTERY. THE LESION WAS MILDLY CALCIFIED AND ECCENTRIC AND WAS 15MM IN LENGTH. THE VESSEL WAS 7.0MM IN DIAMETER. AN ANGIOGUARD WAS PLACED AND A PRECISE STENT WAS IMPLANTED WITHOUT ANY COMPLICATIONS. POST STENT DEPLOYMENT, IT WAS NOTED THAT THE PATIENT HAD BEHAVIORAL CHANGES, APHASIA AND DYSARTHRIA. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE ANGIOGUARD WAS STILL IN PLACE WHEN THE PATIENT EXPERIENCED THE STROKE. THE STENT HAD BEEN PLACED AND THE PATIENT STARTED TO HAVE VERY MILD SYMPTOMS OF A STROKE. LATER ON IN THE NIGHT, THE PATIENT DEVELOPED PROFOUND CHANGES FROM THE STROKE. THE PATIENT WENT TO PHYSICAL, OCCUPATIONAL AND SPEECH THERAPY WHILE IN THE HOSPITAL. THE PATIENT WAS DOING MUCH BETTER, BUT WAS NOT FULLY RECOVERED AT DISCHARGE. THE PATIENT'S MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71007502

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability