BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 7955313 · Received October 11, 2018

    Report

    Report Number
    3001845648-2018-00476
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 11, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231358
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP MDR IS BEING SUBMITTED TO CANCEL THE INITIAL MDR, IT HAS BEEN CONFIRMED THAT THIS FILE IS A DUPLICATE OF A FILE PREVIOUSLY REPORTED WITH FDA MDR REFERENCE NUMBER 3001845648-2018-00487.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS FILE IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. FLEXOR WAS BROKEN, STENT HAS BEEN KEPT, DEVICE AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE FOR ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". FLEXOR WAS BROKEN, STENT HAS BEEN KEPT, DEVICE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796439 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1397534 10827002231358

    Patients

    Seq Age Sex Outcome Treatment
    1