BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLX

    MDR report key: 5195391 · Received November 2, 2015

    Report

    Report Number
    2183870-2015-00428
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    November 10, 2014
    Report Date
    December 1, 2014
    Manufacturer
    PLYMOUTH-PA
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 (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

    THE PHYSICIAN TREATED THE RIGHT COMMON ILIAC ARTERY WITH A PROTÉGÉ GPS, AND STENTING IN THE RIGHT SFA ((B)(6) 2012). APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE: THE PATIENT WAS ADMITTED TO UNDERGO PTA AND ATHERECTOMY DUE TO COMPLAINTS OF RIGHT LOWER EXTREMITY DISCOMFORT ((B)(6) 2014).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726848 PROTEGE EVERFLX STENT, SUPERFICIAL FEMORAL ARTERY NIP PLYMOUTH-PA PRB35-06-040-080 9571271

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention