BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 6487796 · Received April 12, 2017

    Report

    Report Number
    2183870-2017-00164
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    January 19, 2017
    Report Date
    August 7, 2017
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT ALSO HAS A HISTORY OF PREVIOUS PERIPHERAL REVASC IN THE RIGHT COMMON FEMORAL ARTERY AND FEMORAL PROFUNDA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITION INFORMATION RECEIVED 26 JUNE 2017: THE PATIENT WAS A PREVIOUS SMOKER AND ALSO HAD PREVIOUS BTK SURGERY FOR LEFT <(>&<)> RIGHT VASCULAR DISEASE. APPROX 40 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED WITH RE-STENOSIS IN THE LEFT SFA ((B)(6) 2017) AND WAS TREATED APPROX THREE WEEKS LATER ((B)(6) 2017) WITH A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE AND ONE IN.PACT ADMIRAL DEB. THE PATIENT RECOVERED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ((B)(6) 2013), 2 IN.PACT ADMIRAL WERE USED TO TREAT THE LEFT MID SFA AND POPLITEAL ARTERY WITH A DISSECTION PRESENT. APPROX 2 PROTÉGÉ EVERFLEX SELF-EXPANDING STENTS WERE USED TO TREAT RESIDUAL STENOSIS IN THE LEFT MID SFA AND POPLITEAL ARTERY. APPROXIMATELY 40 MONTHS POST PROCEDURE, THE PATIENT SUFFERED RE-STENOSIS IN THE LEFT SFA ((B)(6) 2017) AND WAS TREATED WITH 1 IN.PACT ADMIRAL DEB AND A HAWKONE ATHERECTOMY DEVICE. THE OUTCOME IS REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270231 EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention