BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1002207 · Received February 21, 2008

    Report

    Report Number
    1016427-2008-00042
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    December 19, 2007
    Report Date
    January 24, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    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 CORDIS PRODUCTS THAT WAS INVOLVED IN THIS PROCEDURE AND IS RELATED TO MFG# 9616099-2008-00423 AND 1016427-2008-00042.

    Description of Event or Problem · 1

    TWO DAYS FOLLOWING A CAROTID STENTING PROCEDURE, THE PATIENT SUFFERED A BRAIN INFARCTION. THE PATIENT WAS DIAGNOSED WITH A STROKE. THE PATIENT REMAINED PARALYZED FOR 4/5 DAYS FOLLOWING THIS FINDING. THE PATIENT IS A MALE. THE TARGET LESION WAS THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE CHARACTERISTICS OF THE VESSEL ARE UNKNOWN. PATIENT HISTORY IS UNKNOWN. THERE WAS NO MALFUNCTION REPORTED DURING THE PROCEDURE WITH THE ANGIOGUARD DEVICE AND THE PRECISE STENT. THE IMPLANTATION PROCEDURE WAS COMPLETED WITH NO PROBLEM. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS IN STABLE CONDITION. THERE IS NO INFORMATION AS TO WHAT MEDICATIONS THE PATIENT WAS GIVEN PRE, INTRA, AND POST-PROCEDURE. THE SYMPTOMS OF A STROKE WERE DETECTED TWO DAYS AFTER THE STENT IMPLANTATION. THE INFARCT WAS LOCATED ON THE RIGHT SIDE OF THE CEREBRAL CORTEX. THE PARALYSIS WAS LOCATED IN THE LEFT PART OF THE BODY, MAINLY HYPOSTHENIA OF THE LEGS AND ARMS. THE PHYSICIAN NOTED THAT "IT MAY BE POSSIBLE THAT THE EMBOLUS PASSED THROUGH THE SIDE CLEARANCE BETWEEN THE FILTER AND THE WALL OF CAROTID ARTERY." THE PATIENT HAS SINCE BEEN MOVED TO ANOTHER HOSPITAL FOR REHABILITATION AS HIS ACTIVITIES OF DAILY LIVING (ADL) INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE NTE CORDIS CORPORATION NA 70907513

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L