BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 8294781 · Received January 31, 2019

    Report

    Report Number
    2024168-2019-00734
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    December 15, 2018
    Report Date
    March 18, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER WAS UPDATED FROM 7010441 TO UNK. CORRECTION: MANUFACTURE SITE CHANGED FROM CLONMEL TO TEMECULA. THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED SINCE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN ELECTRONIC INSTRUCTIONS FOR USE PERIPHERAL STENT SYSTEM OMNILINK ELITE, FDA AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY TO POSITION AND STENT DISLODGEMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DISSECTION CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE ACCOUNT CONFIRMED THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID ILIAC ARTERY. A 7.0X59MM OMNILINK ELITE FAILED TO CROSS THE LESION DUE TO AN INTERACTION WITH ANOTHER DEVICE. THE STENT DISLODGED WHILE IN THE PATIENT'S BODY. A DISSECTION OCCURRED AND WAS REPAIRED BY UNKNOWN MEANS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86343 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 7010441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention