BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTÉGÉ ®GPS¿ SELF-EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 2537580 · Received April 17, 2012

    Report

    Report Number
    2183870-2012-00073
    Event Type
    Death
    Date Received
    April 17, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 20, 2012
    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 HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT WAS INFECTED WITH (B)(6).

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). DURING THE IMPLANTATION OF THE PROTEGE STENT, THE TIP OF STENT WAS JUST DEPLOYED WHEN THE PATIENT UNEXPECTEDLY SUFFERED FROM AN ACUTE MYOCARDIAL INFARCTION AND DIED. THE PHYSICIAN RETRIEVED THE STENT AND THE STENT WAS FULLY DEPLOY IN VITRO.

    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. SERP65-06-40-120 9418679

    Patients

    Seq Age Sex Outcome Treatment
    1 Death