BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

    MDR report key: 5488399 · Received March 9, 2016

    Report

    Report Number
    2183870-2016-00209
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Description of Event or Problem · 1

    STENT WAS APPROX. 90 MM LONG INSTEAD OF 120 MM. IT IS REPORTED THAT THE STENT WAS PLACED IN TARGET AREA, MORE OR LESS, NOT FULLY SATISFIED. ANOTHER STENT WAS USED. NO PATIENT HARM OCCURRED. NO INTERVENTION DUE TO EVENT WAS NECESSARY. EXTENSION OF PROCEDURE WAS MORE THAN 30 MINUTES. PLEASE NOTE THAT THIS DEVICE (PROTEGE EVERFLEX STENT WITH ENTRUST DELIVERY SYSTEM) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, THE STENT IS SIMILAR TO THE STENT IN THE UNITED STATES MARKETED DEVICE (PROTEGE EVERFLEX) APPROVED UNDER PMA # P110023. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147174 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN EVX35-06-120-080 9869007

    Patients

    Seq Age Sex Outcome Treatment
    1