BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1985453 · Received February 11, 2011

    Report

    Report Number
    2024168-2011-00830
    Event Type
    Malfunction
    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
    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 STENT: RX ACCULINK 7-10/30 ((B)(4)) OTHER: 5-FRENCH JUDKINS DIAGNOSTIC CATHETER, BIVALIRUDIN EMBOLIC PROTECTION: RX ACCUNET ((B)(4)) THE RX ACCULINK 7-10/30 (PN 1011344-30, LOT 0100561) AND RX ACCUNET (PN 1011649-75, LOT 0092161) ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. EVALUATION SUMMARY: EVALUATION OF THE RETURNED SELF EXPANDING STENT SYSTEM (SES) FOUND BLOOD ON THE HANDLE AND ON AND IN THE SHAFT, CONSISTENT WITH THE REPORTED USE IN THE PATIENT. THERE WAS NO SALINE VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE SHAFT BETWEEN THE MARKERS, INDICATING THAT THE SLIDER HAD NOT BEEN RETRACTED AND THE STENT HAD NOT BEEN DEPLOYED. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE DISTAL OUTER SHEATH WAS RETURNED COVERING THE STENT IMPLANT. THE PROXIMAL END OF THE DISTAL OUTER SHEATH WAS BUNCHED AT THE PROXIMAL MARKER, SUGGESTING RESISTANCE WAS ENCOUNTERED WITHIN THE SHEATH, POSSIBLY DUE TO ADVANCING AGAINST RESISTANCE. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE HYPOTUBE HAD SEPARATED 101.2 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED, SUGGESTING THAT THE HYPOTUBE HAD KINKED PRIOR TO SEPARATING. THE SHAFT COVERING THE HYPOTUBE WAS STRETCHED AND SEPARATED AT THE SAME LOCATION, INDICATING FORCE WAS APPLIED TO SEPARATE THE MATERIAL. THE SEPARATED PORTION WAS RETURNED INSIDE A NON-ABBOTT INTRODUCER SHEATH. THIS HYPOTUBE SEPARATION IS LIKELY THE RESULT OF PUSHING AGAINST RESISTANCE WITH FORCE WHILE ATTEMPTING TO CROSS THE LESION. IF THE SHAFT IS NOT PROPERLY SUPPORTED DURING PUSHING OR ADVANCING AGAINST RESISTANCE, IT MAY CAUSE THE SHAFT TO KINK. IN THIS CASE, ONCE THE SHAFT KINKED, AND UPON STRAIGHTENING, THE HYPOTUBE MATERIAL SEPARATED. THERE WAS 8 CM OF THE DISTAL END OF THE SES EXTENDING PAST THE DISTAL END OF THE COMPETITORS INTRODUCER SHEATH. THE REMAINDER OF THE SEPARATED SHAFT OF THE SES WAS EXTENDING OUT A HOLE IN THE SHAFT OF THE COMPETITORS INTRODUCER SHEATH. THERE WAS 5.5 CM OF THE SEPARATED SES EXTENDING OUT THE HOLE IN THE INTRODUCER SHEATH. THE HYPOTUBE WAS SEPARATED AT THIS LOCATION BUT THE SHAFT WAS HELD TOGETHER BY OUTER SHAFT MATERIAL. AS A RESULT OF THE SEPARATION, DIFFICULTY WAS ENCOUNTERED DURING REMOVAL AND THE RX ACCUNET FILTER, THE SHEATH AND THE WIRE WERE REMOVED AS ONE UNIT THROUGH THE FEMORAL INSERTION. THERE WERE KINKS IN THE HYPOTUBE 15 CM AND 18 CM DISTAL TO THE STRAIN RELIEF TUBING. THESE KINKS MAY ALSO BE THE RESULT OF ADVANCING AGAINST RESISTANCE AND/OR ADDITIONAL HANDLING DURING PACKAGING FOR RETURNED TO ABBOTT VASCULAR FOR INVESTIGATION. THE HANDLE WAS IN THE LOCKED POSITION. THE SLIDER WAS IN THE DISTAL END OF THE HANDLE. THERE WAS NO OTHER DAMAGE NOTED TO THE SES. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY ISSUE. ANALYSIS OF THE RETURNED SES FOUND THAT THE OUTER DIAMETER OF THE SHEATH OVER THE STENT IMPLANT MEASUREMENT MET THE MANUFACTURING CRITERIA. IN THIS CASE, BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY CROSSING WAS A RESULT OF INTERACTION WITH THE 7-10/30 RX ACCULINK STENT THAT WAS PREVIOUSLY PLACED. REPORTEDLY, THE STENT DELIVERY SYSTEM FAILED TO ADVANCE BEYOND THE PROXIMAL BORDER OF THE 7-10X30 RX ACCULINK STENT. ADDITIONALLY, THE PATIENT ANATOMY, WHICH WAS DESCRIBED AS HEAVILY TORTUOUS, MAY HAVE ALSO CONTRIBUTED TO THE DIFFICULTY. THE RX ACCULINK INSTRUCTION FOR USE (IFU) STATES: IF RESISTANCE IS MET DURING DELIVERY SYSTEM INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM USED. IN THIS CASE, THE RESISTANCE MET DURING ADVANCING APPEARS TO BE RELATED TO INTERACTION WITH THE PREVIOUSLY PLACED ACCULINK STENT WHICH WAS INADVERTENTLY DEPLOYED IN AN UNINTENDED LOCATION DUE TO THE STENT JUMPING. THEREFORE, THE ATTEMPT TO ADVANCE THE SECOND ACCULINK DISTAL RESULTING IN RESISTANCE WHILE ADVANCING APPEARS TO BE DUE TO SPECIAL CIRCUMSTANCES OF THE CASE AND NOT NECESSARILY USER RELATED. 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. IN THIS CASE, THE REPORTED DIFFICULTIES AND SUBSEQUENT DAMAGE TO THE RX ACCULINK DELIVERY SYSTEM APPEAR TO BE RELATED TO CASE CIRCUMSTANCES. 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 0092161

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR