BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2191293 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05483
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. POSSIBLE CAUSES FOR RESISTANCE ADVANCING THE OTW OMNILINK THROUGH A 6F NON-ABBOTT SHEATH INCLUDE, BUT ARE NOT LIMITED TO, INCORRECT SIZE SHEATH USED, DAMAGE TO THE STENT OR DAMAGE TO THE INTRODUCER SHEATH. THE OMNILINK ELITE WAS NOT RETURNED FOR ANALYSIS WHICH WOULD HAVE AIDED IN THE INVESTIGATION. HOWEVER, POTENTIAL FACTORS WHICH MAY ALSO CONTRIBUTE TO DIFFICULTY REMOVING THE CATHETER POST STENT DEPLOYMENT INCLUDE, BUT ARE NOT LIMITED TO, ANATOMICAL CONDITIONS, DAMAGE TO THE INTRODUCER SHEATH, DAMAGE TO THE BALLOON, IMPROPER BALLOON REFOLD, BALLOON NOT FULLY DEFLATED, INTERACTION WITH ANATOMY OR ASSOCIATED DEVICES. TO HELP INSURE THE ISSUE IS NOT A POTENTIAL MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THEREFORE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED, AS THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OTW OMNILINK ELITE STENT DELIVERY SYSTEM EXPERIENCED RESISTANCE DURING ADVANCEMENT THROUGH A 6F NON-ABBOTT SHEATH. HOWEVER, THE DEVICE WAS ABLE TO ADVANCE AND BE DEPLOYED AT THE TARGET LESION IN THE COMMON ILIAC ARTERY. DURING RETRACTION OF THE SDS, RESISTANCE WAS FELT AND THE WHOLE SYSTEM WAS REMOVED AS SINGLE UNIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 642490

    Patients

    Seq Age Sex Outcome Treatment
    1