BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 3112384 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03036
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    July 1, 2010
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. DATE OF EVENT ESTIMATED AS ONE YEAR FROM START OF STUDY. DATE OF IMPLANT ESTIMATED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF RESTENOSIS IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE OMNILINK ELITE PERIPHERAL STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE ABSOLUTE PRO REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. BRAVISSIMO: 12-MONTH RESULTS FROM A LARGE SCALE PROSPECTIVE TRIAL.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER, MULTI-NATIONAL, MONITORED TRIAL CONDUCTED AT 12 HOSPITALS IN BELGIUM AND 11 HOSPITALS IN ITALY, IDENTIFIED A TOTAL OF 325 PATIENTS WHO RECEIVED UNKNOWN ABSOLUTE PRO STENTS AND UNKNOWN OMNILINK ELITE STENTS IMPLANTED IN TRANS-ATLANTIC INTER-SOCIETY CONSENSUS (TASC) A/B AND TASC C/D ILIAC LESIONS BETWEEN JULY 2009 AND SEPTEMBER 2010. THE 12-MONTH PRIMARY PATENCY RATE WAS 92% IN LESIONS TREATED WITH THE OMNILINK ELITE STENTS AND 96% IN LESIONS TREATED WITH THE ABSOLUTE PRO STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212490 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other