BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1905027 · Received November 22, 2010

    Report

    Report Number
    3004742046-2010-00542
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE THERE WAS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PROLAPSE AND THERAPY, NON-SURGICAL TREATMENT ARE KNOWN ADVERSE EVENTS. IN THIS CASE, AN XACT STENT WAS IMPLANTED TO TREAT THE TISSUE PROLAPSE (NON-SURGICAL TREATMENT). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED TISSUE PROLAPSE AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    PATIENT WAS REVISED. THE SURGEON STATED HE THOUGHT THE PATIENT HAD A METAL SENSITIVITY PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, MARKED TISSUE PROLAPSE OCCURRED THROUGH THE STENT STRUTS. AN XACT STENT WAS IMPLANTED TO TREAT THE TISSUE PROLAPSE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA 0061561

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention