BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2110520 · Received June 1, 2011

    Report

    Report Number
    2183870-2011-00112
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    March 9, 2011
    Report Date
    May 2, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PATIENT IS ENROLLED IN (B)(6) STUDY: AT AN UNEXPECTED FOLLOW UP, A STENT WAS PLACED TO TREAT AN ANEURYSM IN THE MID TO DISTAL SFA. AREAS OF DISSECTION WERE NOTED MEDIALLY AND PROXIMALLY IN SFA. BOTH AREAS WERE TREATED WITH STENTS WITH GOOD ANOGRAPHIC RESULTS. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. LX-M 9394983

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention