BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2942569 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00628
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 DURING THE PROCEDURE, AFTER ADVANCING A 6.0 MM/29 MM/80 CM OTW OMNILINK ELITE STENT SYSTEM TO A HEAVILY CALCIFIED LESION IN THE RIGHT EXTERNAL ILIAC ARTERY, AN ATTEMPT WAS MADE TO DEPLOY THE STENT VIA BALLOON INFLATION WHEN IT WAS NOTED ANGIOGRAPHICALLY, DURING BALLOON INFLATION, THAT THE STENT WAS NOT ON THE BALLOON. THE BALLOON WAS DEFLATED AND THE OMNILINK SYSTEM WAS WITHDRAWN; DURING THE WITHDRAWAL, THOUGH NOT INTENTIONAL, THE BALLOON WINGS INADVERTENTLY CAUGHT THE DISLODGED AND UNEXPANDED STENT, PULLING IT OUT OF THE ANATOMY WITHOUT ANY RESISTANCE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46802 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 2072741

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR