BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1902307 · Received November 11, 2010

    Report

    Report Number
    3004742046-2010-00530
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 19, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIFFICULTY REMOVING THE CATHETER AFTER STENT IMPLANTATION CAN BE A RESULT OF, BUT IS NOT LIMITED TO, LESION/ANATOMY, INTERACTION WITH A DEPLOYED STENT (STENT APPOSITION), PHYSICIAN TECHNIQUE, ACCESSORY DEVICE SUPPORT AND/OR INTERACTION WITH ACCESSORY DEVICES. ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A POWER-ON-RESET (POR) CONDITION WAS REPORTED AND A "CALL YOUR DOCTOR: POR" ICON MESSAGE WAS SEEN. IT WAS NOTED THAT THE PT HAD REVISION SURGERY TO RELOCATE THE NEUROSTIMULATOR. ADDITIONAL INFO WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT AFTER THE XACT STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY, THE XACT STENT DELIVERY SYS (SDS) WAS DIFFICULT TO REMOVE REQUIRING THE GUIDING CATHETER TO BE ADVANCED INTO THE STENT IN ORDER TO REMOVE THE XACT SDS. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THE PT WAS DISCHARGED TO HOME THE SAME DAY. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-VS NA 0062861

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention OTHER: HEPARIN| EMBOLIC PROTECTION: EMBOSHIELD NAV 6| (PART # 22438-19, LOT# 0060951)