BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 2922914 · Received January 18, 2013

    Report

    Report Number
    2183870-2013-00023
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE, 'NEVER ADVANCE THE DISTAL TIP OF THE CATHETER NEAR THE FLOPPY END OF THE GUIDEWIRE. A CATHETER ADVANCED TO THIS POSITION MAY NOT FOLLOW THE GUIDEWIRE WHEN IT IS RETRACTED AND CAUSE THE GUIDEWIRE TO BUCKLE INTO A LOOP. IF THIS OCCURS, CATHETER AND GUIDEWIRE SHOULD BE REMOVED TOGETHER TO PREVENT POTENTIAL DAMAGE TO VESSEL WALLS. IF RESISTANCE IS STILL FELT, THE SHEATH SHOULD ALSO BE REMOVED AS PART OF THE UNIT."

    Description of Event or Problem · 1

    THE PROCEDURE WAS A THIRD ORDER CATHETER PLACEMENT, SELECTIVE LEFT LOWER ANGIOGRAPHY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ATHERECTOMY OF THE LEFT ANTERIOR TIBIAL ARTERY. DURING THE PROCEDURE IT APPEARED THAT THE EMBOLIC PROTECTION'S WIRE WAS LOOPED WHEN THE PHYSICIAN WAS REMOVING THE SILVERHAWK ES+ DEVICE. THE WIRE IN CONJUNCTION WITH THE 6FR SHEATH CAUSED A SEPARATION OF THE SILVERHAWK DEVICE AT THE CUTTER WINDOW. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE TIP AND MAINTAIN THE EMBOLIC PROTECTION DEVICE SAFELY AND QUICKLY WITH A 4MM SNARE. THREE PASSES WERE PERFORMED WITH THE SILVERHAWK ES+. WHEN THE ATHERECTOMY CATHETER WAS WITHDRAWN, THE PHYSICIAN FELT A SNAP. WHEN THE ATHERECTOMY CATHETER WAS REMOVED THE NOSECONE WAS BROKEN OFF THE CATHETER. SURVEILLANCE WITH FLUOROSCOPY SHOWED THAT THE NOSECONE WAS ACTUALLY IN THE POPLITEAL ARTERY. THE PHYSICIAN USED A SNARE TO REMOVE THE NOSE CONE OUT OF THE POPLITEAL. THE NOSECONE WAS RECOVERED IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27355 SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. P4044 9511237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F PINNACLE DESTINATION SHEATH| GOOSENECK SNARE| SPIDERFX EMBOLIC PROTECTION DEVICE