BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT STANDARD

    MDR report key: 7298559 · Received February 26, 2018

    Report

    Report Number
    2183870-2018-00114
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    July 8, 2013
    Report Date
    February 28, 2018
    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

    CORRECTED INFORMATION: 6X40 EVERFLEX SELF-EXPANDING STENT WAS USED (ALONG WITH 2 IN.PACT ADMIRAL DRUG-ELUTING BALLOONS) DURING THE INDEX PROCEDURE. 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.

    Description of Event or Problem · 1

    THE INDEX PROCEDURE WAS PROMPTED ON (B)(6) 2013 BY A PERSISTENT RESIDUAL STENOSIS IN THE RIGHT MID AND DISTAL SFA. DURING THE INDEX PROCEDURE, TWO IN.PACT ADMIRAL DRUG-ELUTING BALLOONS AND ONE 6X40 EVERFLEX PTA BALLOON WERE USED SUCCESSFULLY. IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, THE PATIENT COMPLAINED OF SLIGHT TINGLING IN BOTH LEGS (NOV 2013), NO TREATMENT WAS GIVEN. APPROXIMATELY 31 MONTHS POST PROCEDURE, THE PATIENT SUFFERED A RESTENOSIS OF THE RIGHT DISTAL SFA ((B)(6) 2016). AFTER DIAGNOSTIC PROCEDURE, THE PATIENT WAS TREATED WITH LITHOPLASTY, DATE OF RESOLUTION ((B)(6) 2018).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141221 EVERFLEX SELF-EXPANDING PERIPHERAL STENT STANDARD STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention