BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .018 STENT DELIVERY SYSTEM

    MDR report key: 2933906 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00474
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. 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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OMNILINK STENT DELIVERY SYSTEM (SDS) WAS INSERTED INTO THE ANATOMY, BUT WAS NOTED TO BE PARTIALLY DEPLOYED ON THE PROXIMAL END. THE OMNILINK SDS WITH THE STENT WAS REMOVED FROM THE PATIENT AND AN UNKNOWN STENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THE INTENDED TARGET LESION WAS ESTIMATED TO BE EITHER THE INFERIOR MESENTERIC ARTERY OR THE RENAL ARTERY. THERE WAS NO ADVERSE PATIENT EFFECT FROM THE DEVICE ISSUE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PARTIALLY DEPLOYED STENT. AFTER REMOVAL FROM THE ANATOMY, ONE STENT STRUT APPEARED TO BE FLARED ON THE PROXIMAL END. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39586 OMNILINK .018 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM NIO AV-TEMECULA-CT 1041561

    Patients

    Seq Age Sex Outcome Treatment
    1