BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SELF-EXPANDING STENT

    MDR report key: 5018507 · Received August 20, 2015

    Report

    Report Number
    2183870-2015-00291
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    April 14, 2014
    Report Date
    July 22, 2015
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. ADDITIONAL INFORMATION ON WHAT COVIDIEN SELF-EXPANDING STENT DEPLOYED HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE INDEX PROCEDURE WAS PERFORMED ON THE RIGHT SFA (B)(6) 2013 AS PART OF THE (B)(6) STUDY. AT THE 30 DAY FOLLOW UP ON (B)(6) 2013 THE PATIENT PRESENTED WITH OCCLUSION OF THE RIGHT SFA WHICH REQUIRED IN-PATIENT HOSPITALIZATION FOR 2 NIGHTS. PTA AND DEPLOYMENT OF 2 COVIDIEN SELF-EXPANDING STENTS (UNKNOWN MAKE AND MODEL)WAS PERFORMED ON (B)(6) 2013. THE STENTS WERE 5X150 AND 5X120. ON (B)(6) 2013 THE PATIENT AGAIN PRESENTED WITH OCCLUSION OF THE RIGHT SFA. SURGICAL INTERVENTION WAS REQUIRED. TEA AND FEMORO-POPLITEAL BYPASS WAS PERFORMED (B)(6) 2013. (B)(6) 2014 THE PATIENT REQUIRED RIGHT LOWER LIMB AMPUTATION. PLEASE REFERENCE MDR 2183870-2015-00290 FOR THE OTHER SELF-EXPANDING STENT USED IN THIS PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552136 UNKNOWN SELF-EXPANDING STENT STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN UNKNOWN SELF-EXPANDING STENT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other