BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1953224 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00165
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 12, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. POTENTIAL CAUSES FOR TIP DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INADVERTENT PULLING ON THE TIP OF THE STENT DELIVERY SYSTEM (SDS) DURING REMOVAL OF THE TIP MANDREL, INSUFFICIENT SUPPORT DURING PREPARATION, INTERACTION DURING LOADING ONTO A GUIDE WIRE, OR INTERACTIONS WITH THE INTRODUCER SHEATH AND/OR ASSOCIATED DEVICES DURING INSERTION. TO ENSURE THIS IS NOT RESULT OF A MANUFACTURING DEFICIENCY, ALL TIPS ARE INSPECTED DURING LOADING OF THE MANDREL ON THE MANUFACTURING LINE. ADDITIONALLY A TIP PULL TEST IS PERFORMED DURING RELIABILITY TESTING ON-LINE. IN THIS CASE, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. IT MAY BE POSSIBLE THAT WHILE REMOVING THE TIP MANDREL, THE TIP OF THE SDS MAY HAVE BEEN INADVERTENTLY GRASPED, AND WHILE PULLING THE TIP WITH THE MANDREL, THE SEPARATION OCCURRED. HOWEVER, WITH OUT THE RETURN OF THE DEVICE, THIS COULD NOT BE CONFIRMED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE TIP DETACHMENT CAN NOT BE DETERMINED THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. RX ACCULINK CAROTID STENT SYSTEM,(PART 1011343-40, LOT 0041461) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE AN ACCULINK STENT (PART 1011343-40, LOT 0041461) WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY AND POST-DILATATION WAS DONE USING A NON-ABBOTT BALLOON. ANGIOGRAM FOLLOWING POST-DILATATION SHOWED A SHELF OF ATHEROMATOUS PLAQUE JUST PROXIMAL TO THE STENT. THEREFORE, AN ACCULINK STENT (PART 1011340-30, LOT 9120351) WAS PREPARED TO COVER THE PLAQUE; HOWEVER, DURING PREPARATION THE TIP OF THE STENT DELIVERY SYSTEM BROKE OFF ON THE TABLE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A THIRD ACCULINK STENT WAS SUCCESSFULLY IMPLANTED PROXIMALLY AT THE BIFURCATION TO TREAT THE PLAQUE SHELF. AN ADDITIONAL STENT WAS THEN IMPLANTED IN THE RIGHT COMMON CAROTID ARTERY, AS PLANNED, TO COVER THE LONG INDEX LESION. THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY AND THERE WAS NO ADVERSE PATIENT SEQUELA. 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-CT 9120351

    Patients

    Seq Age Sex Outcome Treatment
    1