BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1985379 · Received February 11, 2011

    Report

    Report Number
    2024168-2011-00828
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. DIL CATH: 6X20 VIATRAC BALLOON; GUIDE CATH: COOK 6X90; SHEATH: 6-F X 90 CM COOK FLEXOR; OTHER: 5-FRENCH JUDKINS DIAGNOSTIC CATHETER, BIVALIRUDIN; EMBOLIC PROTECTION: RX ACCUNET (PN (B)(4), LOT 0092161). THE RX ACCULINK (PN (B)(4), LOT 0092161) AND THE RX ACCUNET (PN (B)(4), LOT 0092161) ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. INACCURATE DELIVERY CAN BE THE RESULT OF, BUT IS NOT LIMITED TO, INTERACTION WITH LESION/ANATOMY, PHYSICIAN TECHNIQUE/HANDLING, KINKED SHAFT, AND/OR DEVICE POSITIONING. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL ACCULINK STENT SYSTEMS ARE VISUALLY INSPECTED FOR DAMAGE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. IN THIS CASE, IT IS LIKELY THAT ANATOMICAL CONDITIONS (WHICH WERE REPORTED AS HEAVILY TORTUOUS), CONTRIBUTED TO THE REPORTED INACCURATE DELIVERY (STENT JUMPED DISTALLY). A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. OVERALL, THE REPORTED DEPLOYMENT DIFFICULTY APPEARS TO BE RELATED TO CASE CIRCUMSTANCES, AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT COMMON CAROTID ARTERY (RCCA) STENTING PROCEDURE, IN A HEAVILY TORTUOUS VESSEL, THE 7-10/30 RX ACCULINK STENT JUMPED DISTALLY DURING DEPLOYMENT AND COVERED ONLY HALF OF THE LESION. A SECOND UNPLANNED 10X20 RX ACCULINK STENT DELIVERY SYSTEM (SDS) FAILED TO ADVANCE BEYOND THE PROXIMAL BORDER OF THE 7-10X30 RX ACCULINK STENT. THE STENT WAS REMOVED AND THE LESION WAS PRE-DILATED WITH A 5.5MM BALLOON. THE SAME STENT WAS THEN ATTEMPTED TO BE PLACED AGAIN. DUE TO THE TORTUOSITY, THERE WAS A LOT OF MANIPULATION OF THE DEVICE, BUT AGAIN FAILED TO CROSS. AN ATTEMPT WAS MADE TO REMOVE THE STENT DELIVERY SYSTEM (SDS); HOWEVER THE STENT SHAFT BROKE. SINCE IT COULD NOT BE REMOVED, IT WAS DECIDED TO PULL THE RX ACCUNET FILTER, THE SHEATH AND THE WIRE AS ONE UNIT THROUGH THE FEMORAL INSERTION. MANUAL COMPRESSION WAS HELD. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0100561

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention