BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3222722 · Received July 12, 2013

    Report

    Report Number
    2183870-2013-00169
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    PMA / PMN Number
    K053460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE SILVERHAWK DEVICE WAS RECEIVED. THE TORQUE SHAFT DID NOT EXHIBIT ANY DAMAGE OR DEFICIENCIES RELEVANT TO THE REPORTED EVENT. THE CUTTER HEAD ASSEMBLY WAS LOCATED WITHIN THE DISTAL TIP ASSEMBLY LUMEN. THERE WAS APPROXIMATELY 3MM OF UNIDENTIFIED COLLECTED BIOLOGICAL MATERIAL IN THE LUMEN. THE TORQUE SHAFT WAS FLUSHED WITH WATER VIA THE HANDLE ASSEMBLY FLUSH PORT. THE CUTTER DRIVER BACK SWITCH WAS TURNED ON AND THE THUMBSWITCH WAS PULLED BACK TO ACTIVATE THE MOTOR. WHEN THE MOTOR STARTED, THE TORQUE SHAFT TWISTED AND RENDERED THE DEVICE UNTESTABLE FOR FURTHER FUNCTIONAL EVALUATION.

    Description of Event or Problem · 1

    THE PROCEDURE WAS A PERONEAL REVASCULARIZATION, VIA CONTRA LATERAL GROIN ACCESS. THERE WAS PLAQUE SHIFT OR A CLOT PIECE DISLODGED DURING LOADING/REMOVAL AND OR CUTTING WITH THE SILVERHAWK RESULTING IN A SHUTDOWN OF THE PERONEAL AND POSTERIOR TIBIAL ARTERIES AFTER 2 PASSES IN THE PROXIMAL PERONEAL ARTERY. POST-DILATION WITH BALLOON DID NOT RECOVER FLOW. PHYSICIAN CHOSE TO ADMIT THE PATIENT FOR AN OVERNIGHT TPA DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323812 SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. EXL 9708751

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention .014 APPROACH J WIRE