BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3932691 · Received July 14, 2014

    Report

    Report Number
    2024168-2014-04500
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULTY DEPLOYING THE STENT WAS ABLE TO BE CONFIRMED. IN ADDITION, THE DISTAL END OF THE STENT WAS NOTED TO BE EXPOSED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR FAILURE TO DEPLOY REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A LESION IN THE RIGHT INTERNAL CAROTID ARTERY. REPORTEDLY, IT WAS NOT POSSIBLE TO RELEASE THE STENT AS EXCESSIVE RESISTANCE WAS EXPERIENCED RETRACTING THE PROTECTIVE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY AND THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED CORONARY STENT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS NOTED THAT THE DISTAL END OF THE STENT WAS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409785 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 3071261

    Patients

    Seq Age Sex Outcome Treatment
    1