BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1985511 · Received February 11, 2011

    Report

    Report Number
    2024168-2011-00831
    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
    NTE
    PMA / PMN Number
    K052166
    Adverse Event
    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. STENT: RX ACCULINK 7-10/30 (PN 1011344-30, LOT 0100561), RX ACCULINK 10/20 (PN 1011342-20, LOT 0092161) OTHER: 5-FRENCH JUDKINS DIAGNOSTIC CATHETER, BIVALIRUDIN. THE RX ACCULINK 7-10/30 (1011344-30, 0100561) AND RX ACCULINK 10/20 (1011342-20, 0092161) ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX ACCUNET FOUND BLOOD ON THE FILTER ELEMENT, IN THE TIP AND ON THE GUIDE WIRE, CONSISTENT WITH THE REPORTED USE IN THE ANATOMY. THERE WAS SALINE ON THE FILTER ELEMENT. THE FILTER ELEMENT AND THE BAREWIRE WERE RETURNED. THE RECOVERY CATHETER, TRAY AND TORQUE DEVICE WERE NOT RETURNED. THE ACCUNET WAS RETURNED INSIDE THE TIP OF THE ACCULINK. THE FILTER BASKET WAS RETURNED DISTAL TO THE TIP OF THE ACCULINK. THE PROXIMAL END OF THE FILTER BASKET WAS FROZEN INSIDE THE TIP OF THE ACCULINK. THIS IS CONSISTENT WITH THE TECHNIQUE USED TO REMOVE THE DISTAL PORTION OF THE SEPARATED ACCULINK, WHICH WAS BY PULLING THE ACCUNET SYSTEM, WHICH IN TURN PULLED THE ACCULINK WEDGING THE PROXIMAL END OF THE FILTER INTO THE ACCULINK TIP. THERE WERE MULTIPLE BENDS IN THE CORE THROUGHOUT THE ENTIRE LENGTH OF THE GUIDE WIRE, LIKELY DUE TO HANDLING OR MANIPULATION DURING REMOVAL. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THE RX ACCUNET INSTRUCTION FOR USE (IFU) STATES: CARE MUST BE USED WHEN REMOVING THE FILTER BASKET THROUGH A NEWLY DEPLOYED STENT TO MAINTAIN FILTER BASKET INTEGRITY AND TO AVOID DISRUPTING THE STENT GEOMETRY. IN THIS CASE, BASED ON THE REPORTED INFORMATION, IT WAS NOT POSSIBLE TO REMOVE THE RX ACCUNET WITH USE OF THE RETRIEVAL CATHETER DUE TO THE SEPARATED PORTION OF THE ACCULINK BEING LOCATED ON THE DISTAL END OF THE GUIDE WIRE NEAR THE FILTER. THEREFORE, THIS REMOVAL TECHNIQUE WAS NECESSARY TO REMOVE THE DEVICES. IN THIS CASE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE CASE CIRCUMSTANCES. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS REVEALED NO NON-CONFORMING MATERIAL RECORDS FOR THIS LOT.

    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 ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0092161

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention