BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2070034 · Received April 26, 2011

    Report

    Report Number
    2024168-2011-02949
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 EFFECTS OF STENOSIS IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE 7X20 XACT STENT WILL BE REPORTED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A STUDY THAT APPROXIMATELY 7 MONTHS POST XACT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY (RICA), THE ASYMPTOMATIC PATIENT WAS FOUND TO HAVE 80% IN-STENT RESTENOSIS (ISR) VIA ULTRASOUND DURING A ROUTINE FOLLOW-UP VISIT. ON (B)(6) 2011, A CT ANGIOGRAM CONFIRMED THE ISR. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND THE ISR WAS TREATED WITH PLACEMENT OF A 7X20 XACT STENT. THE PATIENT EXPERIENCED HYPOTENSION AND ON (B)(6) 2011 WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0031261

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R