BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3080803 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02611
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. 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. THE ADDITIONAL ABSOLUTE PRO DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MINIMALLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. TWO 6.0 X 20 MM ABSOLUTE PRO'S WERE USED IN THE SAME PROCEDURE. WHEN THE THUMBWHEEL ON BOTH DEVICES WERE TURNED TWO CLICKS THE CATHETER STAYED IN POSITION, BUT THE STENTS JUMPED DISTAL TO THE LESION PARTIALLY INTO HEALTHY TISSUE. A COVERED STENT WAS USED TO COVER BOTH OF THE ABSOLUTE PRO'S AND THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182735 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 2042161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention