BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ¿EVERFLEX¿ SELF EXPANDING BILIARY STENT SYSTEM

    MDR report key: 2961616 · Received February 14, 2013

    Report

    Report Number
    2183870-2013-00042
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE MODEL AND LOT NUMBER WERE NOT AVAILABLE. THE INSTRUCTIONS FOR USE (IFU) STATE, "NOTE: IF A SECOND STENT IS NEEDED, PLACE THE MORE DISTAL STENT FIRST. IF OVERLAP OF SEQUENTIAL STENTS IS NECESSARY, THE AMOUNT OF OVERLAP SHOULD BE KEPT TO A MINIMUM. CAUTION: THE EFFECTS OF OVERLAPPING STENTS HAVE NOT BEEN EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING THE FULL MODEL NUMBERS OF THE STENTS DEPLOYED. SHOULD THEY BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. STENTS IMPLANTED IN (B)(6) 2012.

    Description of Event or Problem · 1

    THE PROTEGE EVERFLEX STENTS WERE ORIGINALLY DEPLOYED IN OVERLAPPING FASHION PRIOR TO THE START OF THE VISIBILITY ILIAC PROCEDURE ON (B)(6) 2012. FOUR PROTEGE EVERFLEX STENTS WERE IMPLANTED DURING THE STUDY PROCEDURE OVERLAPPING IN THE LEFT SFA, NON-TARGET LESION. WHEN THE SUBJECT CAME IN FOR THEIR 9 MONTH VISIT IN (B)(6) 2013, IT WAS NOTED THAT THERE WAS AN OCCLUSION AFFECTING 2 OF THE DEPLOYED PROTEGE EVERFLEX STENTS; THE 6X30 PROTEGE EVERFLEX STENT AND ONE OF THE PROTEGE EVERFLEX LONG (UNKNOWN MODEL NUMBER) STENTS. IN THE OTHER PROTEGE EVERFLEX LONG STENT A THROMBUS WAS SEEN AT THE DISTAL END OF THE STENT IN THE LEFT SFA. THERE WERE NO ISSUES WITH THE 4TH STENT REPORTED. ADDITIONAL STENTS WERE DEPLOYED WITHIN THESE STENTS TO RESOLVE THE ISSUE. PLEASE REFERENCE MDRS 2183870-2013-0040 AND 2183870-2013-0041 FOR THE OTHER PROTEGE EVERFLEX STENTS REFERENCED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64371 PROTÉGÉ ¿EVERFLEX¿ SELF EXPANDING BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention VIABAHN STENT| 2 PROTEGE EVERFLEX STENTS