BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3953590 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04719
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    June 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AGAINST RESISTANCE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULTY DEPLOYING THE STENT WAS NOT ABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE RESISTANCE WAS NOT ABLE TO BE CONFIRMED AS IT WAS BASED ON CASE CIRCUMSTANCES. THE REPORTED KINK WAS CONFIRMED. BASED ON A VISUAL AND DIMENSIONAL 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 REPORTED FOR FAILURE TO DEPLOY FOR THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THE RX ACCULINK INSTRUCTION FOR USE (IFU) STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING ACCESS OR DELIVERY SYSTEM REMOVAL, THE GUIDING CATHETER OR SHEATH AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OF OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. IN THIS CASE, IT COULD NOT BE DETERMINED IF ADVANCING AGAINST RESISTANCE CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE ECCENTRIC, MILDLY TORTUOUS, 85% STENOSED, DISTAL INTERNAL CAROTID ARTERY. DUE TO THE TORTUOSITY OF THE VESSEL IT WAS DIFFICULT TO ADVANCE THE 6-8/40 RX ACCULINK II STENT DELIVERY SYSTEM (SDS) ACROSS THE LESION. AFTER SEVERAL ATTEMPTS, THE SDS FINALLY CROSSED; HOWEVER, DEPLOYMENT OF THE STENT FAILED. THE SDS WAS RETRACTED FROM THE ANATOMY AND IT WAS CONFIRMED THAT THE STENT WAS NOT EXPOSED OR FLOWERING. THERE WAS A BEND/KINK OBSERVED IN THE AREA THE STENT IS LOCATED. A NEW ACCULINK SDS WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS EXPOSED AND THE HYPTOTUBE WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430775 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 3101761

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR