BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

    MDR report key: 3782094 · Received April 30, 2014

    Report

    Report Number
    2183870-2014-00080
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHYSICIAN INSERTED THE 8X60 PROTEGE EVERFLEX INTO ILIOFEMORAL ARTERY. THE STENT DEPLOYED SUCCESSFULLY, HOWEVER UPON POST DILATION WITH A 7MM X 60MM, THE PHYSICIAN NOTED THAT THERE WAS A LENGTH DIFFERENCE IN THE STENT, THAN THE BALLOON. INVESTIGATION OF CINE IMAGES RECEIVED FROM THE PROCEDURE INDICATES THE STENT WAS DEPLOYED IN AN ELONGATED CONFIGURATION. THE IMAGES OF THE DEPLOYED STENT PRESENT INDICATIONS OF STRUT ELONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260938 PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN PRB35-08-060-120 9836067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other