BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 2900210 · Received January 7, 2013

    Report

    Report Number
    2024168-2013-00128
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY WITH MILD CALCIFICATION. THE 9 X 100 MM X 80 CM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT ISSUE TO THE LESION. DURING DEPLOYMENT, THE THUMBWHEEL STOPPED TURNING AND THE STENT WAS PARTIALLY DEPLOYED IN THE ILIAC ARTERY. THE STENT COULD NOT BE FULLY DEPLOYED; THEREFORE, THE SHEATH WAS ABLE TO BE ADVANCED OVER THE STENT AND THE WHOLE SYSTEM WAS REMOVED WITHOUT ISSUE. A NON-ABBOTT SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6946 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 1120761

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR