BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1903755 · Received November 20, 2010

    Report

    Report Number
    3004742046-2010-00544
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (PART #22438-19, LOT #0031651) THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (PART #22438-19, LOT #0031651)REPORTED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN AND ON THE ENTIRE LENGTH OF THE SELF EXPANDING STENT SYSTEM (SES) AND NO SALINE VISIBLE, WHICH IS CONSISTENT WITH USE OF THE PRODUCT. THE STENT IMPLANT WAS NOT RETURNED. THE DISTAL OUTER SHEATH WAS NOT RETRACTED. THE HANDLE WAS IN AN UNLOCKED POSITION. THE SLIDER WAS AT THE DISTAL POSITION OF THE HANDLE. IN THIS CASE, IT WAS REPORTED THE ACCULINK STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, THE STENT BECAME DAMAGED DUE TO THE RETRIEVAL ATTEMPTS OF THE FILTER. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED DIFFICULTIES INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE ACCESSORY DEVICES WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED OR DAMAGE TO THE STENT. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. THERE WAS NO NOTE OF ANY DAMAGE TO THE STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IN THIS CASE, A CONCLUSIVE CAUSE ON WHY THE RECOVERY CATHETER BECAME CAUGHT ON THE DEPLOYED STENT COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEPLOYING A RX ACCULINK STENT IN A VERY TORTUOUS LEFT INTERNAL CAROTID ARTERY AND AS THE EMBOSHIELD NAV6 RECOVERY CATHETER (RC) WAS BEING ADVANCED THROUGH THE STENT, IT BECAME CAUGHT IN THE STENT STRUT. TO HELP RELEASE THE RC, THE NON-ABBOTT SHUTTLE SHEATH WAS ADVANCED TO THE PROXIMAL EDGE OF THE STENT. AS THE RC WAS BEING MANUEVERED IN AN ATTEMPT TO RELEASE IT FROM THE STENT, THE FILTER MIGRATED TO THE DISTAL EDGE OF THE STENT. THE RC WAS RELEASED AND THE FILTER WAS CAPTURED AND REMOVED. DUE TO THE MANIPULATION OF THE RC, THE RX ACCULINK STENT WAS DEFORMED AT THE PROXIMAL AND MIDDLE SECTIONS OF THE STENT. A MIDDLEWEIGHT GUIDE WIRE WAS INSERTED AND A RX VIATRAC BALLOON CATHETER THAT WAS USED FOR POST DILATATION WAS REINSERTED INTO THE STENT AND INFLATED AT 4 ATMOSPHERES FOR 8 SECONDS. AFTER THE CATHETER WAS REMOVED, THE STENT'S PROXIMAL END NEEDED ADDITIONAL ADJUSTMENTS AND ANOTHER RX VIATRAC CATHETER WAS INSERTED AND INFLATED TO 10 ATMOSPHERES FOR 7 SECONDS. THE STENT "LOOKED GOOD". THERE WAS NO FURTHER STENT ADJUSTMENTS. 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 0062961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention