BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 4103133 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06066
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 26, 2014
    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) - RECRIMPED STENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE OTW OMNILINK ELITE STENT DELIVERY SYSTEM WAS RETURNED WITHOUT THE STENT AS THE STENT WAS IMPLANTED; THUS, THE REPORTED LOOSE STENT WAS NOT CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE OTW OMNILINK ELITE INSTRUCTIONS FOR USE (IFU), STATES: CAREFULLY INSPECT THE OMNILINK ELITE PERIPHERAL STENT SYSTEM PRIOR TO USE TO VERIFY THAT THE STENT HAS NOT BEEN DAMAGED IN SHIPMENT AND THAT THE DEVICE DIMENSIONS ARE SUITABLE FOR THE SPECIFIC PROCEDURE. TAKE CARE TO AVOID UNNECESSARY HANDLING. ADDITIONALLY, THE IFU STATES: DO NOT ROLL THE MOUNTED STENT WITH YOUR FINGERS AS THIS ACTION MAY LOOSEN THE STENT FROM THE DELIVERY BALLOON. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TREATING A LESION IN THE LOWER EXTREMITY. DURING INSERTION OF THE 7.0X39MM OMNILINK ELITE 35 PERIPHERAL STENT SYSTEM INTO THE SHEATH, IT WAS NOTED THAT THE STENT WAS NOT TIGHTLY CRIMPED ON THE BALLOON. THE STENT WAS MANUALLY CRIMPED TIGHT ON THE BALLOON AND CONTINUED TO BE USED. THE STENT WAS IMPLANTED SUCCESSFULLY. 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
    582030 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 4040441

    Patients

    Seq Age Sex Outcome Treatment
    1