BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

    MDR report key: 5488395 · Received March 9, 2016

    Report

    Report Number
    2183870-2016-00208
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    June 3, 2014
    Report Date
    July 1, 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

    IT WAS REPORTED THAT DURING INDEX PROCEDURE THE RIGHT DISTAL SFA WITH TREATED WITH TWO EVERFLEX DEVICES. THE DOCTOR INDICATED THE STENTS WERE DEPLOYED AS INTENDED, HOWEVER RECENTLY RECEIVED CORE LAB ANALYSIS SHOW STENT ELONGATION FOR BOTH STENTS CINE IMAGE EVALUATION SUMMARY: THE CINE IMAGES DOCUMENT THE PRE-DEPLOYMENT LENGTH A TARGET LESIONS OF BOTH STENTS AND THE POST-DEPLOYMENT LENGTH, POSITION AND CONFIGURATION OF THE SAME STENTS. THE IMAGES INDICATE A SIGNIFICANTLY CALCIFIC AND DIFFUSED DISEASE TARGET VESSEL. THE DEPLOYED STENTS REFLECTED SOME OF THE IRREGULAR PROFILE GENERATED BY THE DISEASED VESSEL LUMEN. THE IRREGULAR PROFILE CAN GENERATE GAPS IN THE STENT/ STRUT PROFILE THAT MIGHT APPEAR TO BE BREAKS OR ELONGATIONS OF THE STENT. THERE WERE ALSO SEVERAL STRUT DEFORMATIONS THAT DIRECTLY INDICATE AN ELONGATION OF THE STENT. STENT ELONGATION HAS BEEN OBSERVED WHEN THE STENT DELIVERY SYSTEM IS NOT HELD IN A FIXED POSITION WHILE THE STENT IS BEING DEPLOYED. '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
    146414 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN EVX35-08-100-150 9707441

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Other