BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2091587 · Received May 17, 2011

    Report

    Report Number
    2183870-2011-00098
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    April 18, 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 PROCEDURE IS PART OF THE (B)(6) SUBJECT: ON (B)(6), 2010, THE PATIENT PRESENTED WITH AN OCCLUDED POPLITEAL ARTERY. THIS WAS TREATED IN THE PAST USING SILVERHAWK MS-M AND SILVERHAWK SS+ DEVICES; HOWEVER, THERE WAS A RESIDUAL DISSECTION PLANE SEEN. THE PATIENT WAS GIVEN MEDICATION THERAPY TO SEE HOW EXTENSIVE THE DISSECTION PLANE WAS, AND RETURNED FOR TREATMENT. THEN ON (B)(6), 2010 THE SUBJECT WAS IN (B)(6) AND PRESENTED TO THE VASCULAR SPECIALIST WITH ISCHEMIC REST PAIN IN THE LEFT LEG. SURGEON FELT BEST OPPORTUNITY FOR LIMB SALVAGE WAS A FEMORAL TO POSTERIOR TIB BYPASS. PLEASE REFERENCE MDR 2183870-2011-00098 FOR THE OTHER SILVERHAWK USED IN THE (B)(4) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. SS+ 8555792

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other SILVERHAWK MS-M