BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 5359524 · Received January 12, 2016

    Report

    Report Number
    3001845648-2016-00010
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Date of Event
    October 8, 2015
    Report Date
    February 9, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES RELATING TO THIS EVENT WERE RECEIVED AND REVIEWED. THIS IMAGE REVIEW CONFIRMED THIS ZILVER FLEX STENT DEPLOYED NORMALLY. NO FORESHORTENING/KINKING AS INITIALLY REPORTED WAS NOTED WITH THIS STENT.

    Additional Manufacturer Narrative · 1

    THESE ZILVER FLEX DEVICES ARE CLEARED BUT NOT MARKETED IN THE US. THESE DEVICES ARE APPROVED IN THE US FOR ILIAC INDICATION ONLY ALSO. INDICATION FOR USE HAS BEEN CONFIRMED AS ILIAC IN THIS INSTANCE THEREFORE FDA MDR REPORTING GUIDELINES APPLICABLE TO THIS EVENT. FDA REPORT REQUIRED BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR 'STENT KINKING DURING IMPLANTATION' AND 'STENT SHORTENING DURING DEPLOYMENT'. PMA/510(K)#: P050017/S006. THIS EVENT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    THESE ZILVER FLEX DEVICES ARE CLEARED BUT NOT MARKETED IN THE US. THESE DEVICES ARE APPROVED IN THE US FOR ILIAC INDICATION ONLY ALSO. INDICATION FOR USE HAS BEEN CONFIRMED AS ILIAC IN THIS INSTANCE THEREFORE FDA MDR REPORTING GUIDELINES APPLICABLE TO THIS EVENT. FDA REPORT REQUIRED BASED ON THE MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY FOR 'STENT KINKING DURING IMPLANTATION' AND 'STENT SHORTENING DURING DEPLOYMENT'. PMA/510(K)#: P050017/S006. THIS EVENT IS CURRENTLY STILL UNDER INVESTIGATION AND IMAGES ARE CURRENTLY STILL BEING REVIEWED BY AN INDEPENDENT REVIEWER. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT. IMAGES RELATING TO THIS EVENT WERE RECEIVED AND REVIEWED. THIS IMAGE REVIEW CONFIRMED THIS ZILVER FLEX STENT DEPLOYED NORMALLY. NO FORESHORTENING/KINKING AS INITIALLY REPORTED WAS NOTED WITH THIS STENT. PLEASE NOTE THAT A SECOND STENT WAS ALSO REPORTED AS INVOLVED IN THIS EVENT. THIS REPORT REMAINS VALID FOLLOWING THE IMAGE REVIEW - REFERENCE REPORT # 3001845648-2016-00008.

    Description of Event or Problem · 1

    THE ZILVER STENT FORESHORTENED AND KINKED ON DELIVERY. ALTHOUGH REQUESTED NO FURTHER DETAILS HAVE BEEN RECEIVED RELATING TO THIS EVENT. THIS EVENT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THIS EVENT IS CURRENTLY STILL UNDER INVESTIGATION AND IMAGES ARE CURRENTLY STILL BEING REVIEWED BY AN INDEPENDENT REVIEWER. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19985 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR