BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX

    MDR report key: 3020146 · Received March 25, 2013

    Report

    Report Number
    2183870-2013-00068
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    March 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    EV3
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PER MEDWATCH FORM RECEIVED (B)(6) 2013: STENT DID NOT DEPLOY CORRECTLY: PER RADIOLOGIST DICTATION.... DEPLOYMENT OF RIGHT AND LEFT BILIARY STENTS. INITIALLY, THERE WAS PARTIAL MALDEPLOYMENT OF THE RIGHT-SIDED BILIARY STENT DUE TO STENT FAILURE. THIS WAS SUCCESSFULLY OVERCOME BY MANIPULATION AND PLACEMENT OF A COAXIAL BRIDGING STENT WITH EXCELLENT MORPHOLOGIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121855 PROTEGE EVERFLEX CATHETER, BILIARY STENT FGE EV3 PRB35-07-120-120 9449620

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention