BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2911190 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00241
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE LOOSE STENT WAS ABLE TO BE CONFIRMED AS THE STENT WAS RETURNED DISLODGED FROM THE BALLOON. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: TERUMO 0.035, SHEATH: 6 FR COOK. THE DEVICE HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT COMMON ILIAC ARTERY, BELOW THE BIFURCATION, A 0.035 NON-ABBOTT GUIDE WIRE AND A 6 FR NON-ABBOTT SHEATH WERE PLACED SUCCESSFULLY. AS THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED OVER THE GUIDE WIRE OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE STENT WAS LOOSE ON THE BALLOON AND COULD BE MOVED. THE DEVICE WAS NOT USED IN THE ANATOMY. A DIFFERENT OMNILINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17756 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 1112141

    Patients

    Seq Age Sex Outcome Treatment
    1