BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

    MDR report key: 5488409 · Received March 9, 2016

    Report

    Report Number
    2183870-2016-00211
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    January 14, 2014
    Report Date
    July 22, 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 AN EVERFLEX ENTRUST WAS USED IN THE LEFT AFS IN THE MIDDLE SEGMENT (60-70% STENOSIS) AND A 80% STENOSIS IN THE MIDDLE, UPON FOLLOW UP MULTIPLE STENT FRACTIONS WERE NOTICED. THE VESSEL WAS PRE AND POST DILATED WITH A BALLOON. EVENT OCCURRED AFTER PROCEDURE, NO PATIENT HARM, NO SURGICAL OR MEDICAL INTERVENTION REQUIRED DUE TO EVENT. EVALUATION SUMMARY: A CD DISK WITH 45 FILES OF CINE IMAGES FROM THE PROCEDURE WAS RECEIVED. CINE FILE-12 SHOWS THE VESSEL STRUCTURE PRIOR TO ANGIOPLASTY. CINE FILE-11 SHOWS THE VESSEL BEING PRE-DILATED WITH A BALLOON PER THE INITIAL REPORT. CINE FILE-13 SHOWS THE VESSEL WITH STENT IN PLACE WITH POST-DILATION IN PROCESS: STENT EXHIBITS AREAS OF COMPRESSION FROM LESIONS. CINE FILE-16 SHOWS THE VESSEL WITH STENT AFTER POST-DILATION: STENT EXHIBITS AREAS OF COMPRESSION FROM LESION EVEN AFTER POST DILATION. CINE FILE-29 SHOWS THE FULL LENGTH OF THE STENT: AREAS IN PREVIOUS CINES EXHIBITING STENT COMPRESSION NOW SHOW RADIAL AND OFF-SET PSEUDO-FRACTURES. CINE FILE-36 SHOWS THE STENT BEING PRE-DILATED IN PREPARATION OF AN EVX6/150 STENT BEING IMPLANTED PER THE INITIAL REPORT. CINE FILE-40 SHOWS THE EVX6/150 IMPLANTED WITHIN THE EVX7/150 AND BEING POST DILATED. CINE FILE-43 SHOWS THE EVX6/150 IMPLANTED WITHIN THE EVX7/150. 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
    146496 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN EVX35-07-150-120 9669613

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR