BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1053426 · Received May 27, 2008

    Report

    Report Number
    1016427-2008-00155
    Event Type
    Injury
    Date Received
    May 27, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2008-00155 AND 9616099-2008-01399.

    Description of Event or Problem · 1

    THE CAROTID STENTING PROCEDURE WAS COMPLETED WITHOUT ANY ANOMALIES, BUT THE PATIENT DEVELOPED HEMIPLEGIA A FEW HOURS AFTER THE PROCEDURE. THE HEMIPLEGIA COMPLETELY DISAPPEARED SOON AFTER THE ONSET OF THE SYMPTOMS, AND THERE ARE NO REMAINING SYMPTOMS. THERE IS NO INFORMATION AVAILABLE REGARDING THE PATIENT'S AGE AND GENDER, OR TARGET LESION CHARACTERISTICS. THE TARGET LESION WAS CAROTID ARTERY (SIDE UNKNOWN). IT IS UNKNOWN IF THE HEMIPLEGIA WAS MEDICALLY TREATED OR IF THE SYMPTOMS RESOLVED ON THEIR OWN. THERE WAS NORMAL BLOOD FLOW IN THE CEREBRAL ARTERIES AFTER THE STENT WAS PLACED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. IT IS UNKNOWN IF THERE WAS THROMBUS PRESENT AT THE DELIVERY SITE. AFTER THE EVENT OCCURRED, THE PHYSICIAN COMMENTED THAT DURING THE PROCEDURE, SOME THROMBUS COULD HAVE FLOWED DISTAL IN THE VESSEL.

    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 70108502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L LOT 13357607| PRECISE