BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 3973796 · Received August 1, 2014

    Report

    Report Number
    2024168-2014-04925
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE NARROW CAROTID ARTERY. DURING WITHDRAWAL OF THE ACCUNET EMBOLIC PROTECTION SYSTEM (EPS), RESISTANCE WAS MET WITH THE TIGHT VESSEL AND THE GUIDE WIRE WITH THE FILTER ATTACHED SEPARATED. ATTEMPTS TO SNARE THE SEPARATED ACCUNET GUIDE WIRE AND FILTER WERE UNSUCCESSFUL. DUE TO THE MULTIPLE ATTEMPTS TO SNARE THE SEPARATED ACCUNET, THERE WAS SIGNIFICANT BACK-BLEEDING THROUGH THE GUIDING CATHETER. AS A RESULT, THE PATIENT RECEIVED AN UNPLANNED BLOOD TRANSFUSION AND WAS ADMINISTERED UNPLANNED ANTIBIOTICS. A 5.0MMX40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, IT MET RESISTANCE WITH THE GUIDING CATHETER DUE TO THE GUIDING CATHETER SIZE AND WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT BDC WAS USED TO CRUSH THE ACCUNET WIRE AND FILTER AGAINST THE VESSEL WALL. THE TARGET LESION WAS TREATED WITH DEPLOYMENT OF TWO ACCULINK STENTS. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE; HOWEVER, THE PATIENT RECOVERED WELL AND WAS DISCHARGED AS PLANNED WITH NO PROLONGED HOSPITALIZATION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450486 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 3093061

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention