BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2033047 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02152
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF OCCLUSION, PAIN AND THERAPY/NON-SURGICAL TREATMENT ARE KNOWN ADVERSE AND NO-FAULT EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE RX VIATRAC, IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIGHLY CALCIFIED FOCAL LESION OF THE RIGHT INTERNAL CAROTID PROCEDURE WITH MINIMUM VESSEL FLOW, THE EMBOSHIELD NAV6 WAS PLACED AND A VIATRAC WAS USED FOR PREDILATATION WITH A DISSECTION NOTED, FOLLOWED BY A RX ACCULINK STENTING. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN IN THE NECK AREA. THE PATIENT WAS GIVEN FENTANYL AND VERSED FOR PAIN AND THE DISSECTION. IT WAS NOTED THAT THE VESSEL FLOW DID NOT APPEAR TO BE IMPROVED AFTER THE STENTINGS AND THE PHYSICIAN CHOSE TO PLACE A NON-ABBOTT STENT DISTAL TO THE RX ACCULINK. THE FLOW WAS NOT IMPROVED AND THE PATIENT DID NOT HAVE ANY REPORTED ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED 3/7/2011. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0102361

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention EMBOLIC PROTECTION: EMBOSHIELD NAV6