BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1212588 · Received October 24, 2008

    Report

    Report Number
    1016427-2008-00279
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    June 11, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    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. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT WAS PERFORMED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBER: 9616099-2008-02520. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED HYPOTENSION. THE EVENT WAS TREATED PHARMACOLOGICALLY. THE REPORT RECEIVED INDICATED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, A 5MM ANGIOGUARD WAS ADVANCED AND POSITIONED WITHOUT COMPLICATIONS AND A 10X40MM PRECISE STENT WAS SUCCESSFULLY PLACED. HOWEVER, AFTER THE STENT PLACEMENT, THE PATIENT'S BLOOD PRESSURE DROPPED; THEREFORE, VASOPRESSOR (ETILEFRINE) WAS ADMINISTERED TO THE PATIENT AND THE SYMPTOM RECOVERED. THE PATIENT RECOVERED FROM THE HYPOTENSION AND WAS DISCHARGED FROM THE HOSPITAL. FURTHER INFORMATION INDICATED THE PROCEDURE-INCLUDED TREATMENT OF A LESION IN THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS NOT CALCIFIED AND PRESENTED 60% STENOSIS. HE RECOVERED AND IS OUT OF THE HOSPITAL NOW.

    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 70408504

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention AND MEVALOTIN AND WAS ADMINISTERED HEPARIN| THE PATIENT HAS BEEN TAKING ASPIRIN| THE DAY OF THE PROCEDURE.