BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®GPS¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 2415980 · Received January 13, 2012

    Report

    Report Number
    2183870-2012-00010
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 15, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 RELATING TO THIS REPORT HAS BEEN REQUESTED. SHOULD INFORMATION BECOME AVAILABLE AS SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6):THE TIP OF THE DELIVERY CATHETER WAS BROKEN WHILE USING IN THE PATIENT. NO INJURY REPORTED.AN IMAGE RECEIVED FOR EVALUATION INDICATE THAT THE STENT WAS USED WITHIN ANOTHER LATERALLY COMPRESSED STENT (UNKNOWN MAKE/MODEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®GPS¿ SELF EXPANDING PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. SERP65-06-150-120 9449879

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention