BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2366436 · Received December 12, 2011

    Report

    Report Number
    2183870-2011-00228
    Event Type
    Injury
    Date Received
    December 12, 2011
    Date of Event
    November 11, 2011
    Report Date
    November 14, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT HAD A CHRONIC TOTAL OCCLUSION (CTO) OF THE SFA WITH PREVIOUS STENT PLACEMENT FROM A PREVIOUS INTERVENTION. THE STENT HAD BEEN IMPLANTED FOR SEVERAL YEARS. THE CTO WAS CROSSED WITH STANDARD INTERVENTIONAL TECHNIQUE. THE LESION WAS BALLOONED AND ULTIMATELY THE SILVERHAWK LXM WAS USED TO TREAT THE DISEASE. A LUMEN WAS CREATED WITH SLUGGISH FLOW AND A CLOT APPEARED TO BE PRESENT. AFTER SEVERAL PASSES WITH THE SILVERHAWK LX-M, THE DEVICE WAS REMOVED AND CLEANED. AN ANGIOGRAM SHOWED SLUGGISH FLOW AND APPARENT CLOT. A SECOND SET OF PASSES WAS ATTEMPTED. AFTER THIS USAGE OF THE SILVERHAWK DEVICE, AN ANGIOGRAM CONFIRMED NO IMPROVEMENT WITH APPARENT CLOT PRESENT. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND NOTED THAT THE PATIENT WOULD REQUIRE BYPASS SURGERY. AN ANGIO WAS NOT TAKEN DOWN TO THE FOOT AFTER THE SECOND USAGE OF THE SILVERHAWK DEVICE. APPROXIMATELY ONE HOUR LATER THE PHYSICIAN NOTED THAT THE FOOT WAS VERY WHITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. P4055 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention