BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 3183000 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03880
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE REPORTED PATIENT EFFECT OF STROKE IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE RX ACCUNET INSTRUCTIONS FOR USE. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE TWO OTHER DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. ESTIMATED PATIENT AGE AND WEIGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMBOSHIELD NAV6 WAS DEPLOYED ABOVE THE MODERATE TO HEAVILY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION. THE 6-8X30 RX ACCULINK WAS DEPLOYED AT THE BIFURCATION OF THE LEFT INTERNAL AND COMMON CAROTID ARTERY, THEN THE STENT WAS POSTDILATED AND APPEARED TO BE FULLY APPOSED TO THE VESSEL WALL. THE EMBOSHIELD NAV6 RETRIEVAL CATHETER WAS ADVANCED, BUT UNABLE TO CROSS THE IMPLANTED RX ACCULINK STENT. AFTER APPROXIMATELY ONE HOUR OF TRYING TO ADVANCE THE RETRIEVAL CATHETER (RC), THE RC WAS REMOVED AND A SECOND PHYSICIAN INSERTED THE ACCUNET RC, BUT WAS ALSO UNABLE TO PASS THE IMPLANTED STENT. THE PATIENT THEN HAD STROKE SYMPTOMS WITH INABILITY TO SPEAK AND PROBLEMS WITH LEFT SIDED MOVEMENT. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE FILTER AND EXPLANT THE STENT. SURGERY WENT WELL. LATER IN THE DAY, THE PATIENT WAS NOTED TO BE DOING WELL AND WAS SPEAKING. THE PATIENT'S MOVEMENT WAS REGAINED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283642 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S STENT: RX ACCULINK