BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2872989 · Received December 13, 2012

    Report

    Report Number
    2024168-2012-07922
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULTIES DEPLOYING THE STENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION REVIEW OF THE RETURNED DEVICE AND CINE REVIEW OF THE PROCEDURE, 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). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET 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 DEPLOYMENT OF THE OMNILINK ELITE STENT, IT NOT DEPLOY CORRECTLY, AS THE DISTAL END OF THE STENT DID NOT OPEN FULLY. ANOTHER STENT WAS IMPLANTED TO ENSURE THAT THE OMNILINK ELITE STENT WAS FULLY APPOSED TO THE VESSEL WALL. NO ADVERSE PATIENT SEQUELA WAS 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 2062241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention