BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSPIRE

    MDR report key: 3213944 · Received July 9, 2013

    Report

    Report Number
    3007289746-2013-00002
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SPINE VIEW INC.
    Product Code
    HRX
    PMA / PMN Number
    K110992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ACCOUNTS PROVIDED BY THE DISTRIBUTOR, DOCTOR AND SPINE VIEW FIELD PERSONNEL, THERE WAS NO DEVICE MALFUNCTION. INDEED, ON A FOLLOW-UP CALL BY SPINE VIEW VP FOR SALES, THE SURGEON INDICATED THE DEVICE PERFORMED AS INTENDED IN TERMS OF REMOVING TISSUE FROM THE DISC. ON (B)(6) 2013, A CONFERENCE CALL BETWEEN THE DOCTOR AND SPINE VIEW PERSONNEL (VP SALES, RA, R&D) WAS MADE. IT WAS ASCERTAINED THAT THE PT WAS CONTINUING WELL IN RECOVERY. IT WAS ALSO NOTED THAT THERE COULD HAVE BEEN A FISSURE IN THE ANNULUS WHICH MADE IT WEAK. VP SALES MADE SUBSEQUENT CALL TO THE REGIONAL SALES MANAGER AND TO THE DISTRIBUTOR AND CONFIRMED THAT THE SURGEON HAD RECEIVED APPROPRIATE TRAINING ON DEVICE USE WHICH INCLUDES A POTENTIAL COMPLICATION AS STATED IN THE IFU THAT THE ENSPIRE FLEX DEVICE SHOULD NEVER BE IN DIRECT CONTACT WITH ANY NERVOUS TISSUES OR VASCULAR STRUCTURE WHICH COULD RESULT IN VESSEL DAMAGE OR INJURY AND A CAUTION TO AVOID USE OF EXCESSIVE FORCE. THE DEVICE WAS DISCARDED AT USER FACILITY AND WAS NOT RETURNED FOR EVAL BUT DEVICE HISTORY FILES WERE REVIEWED AND SHOWED THAT THE DEVICE LOT MET ALL RELEASE CRITERIA. IT IS LIKELY THAT THE ANNULUS MAY HAVE BEEN DEFECTIVE OR EXCESSIVE FORCE WAS APPLIED TO DEVICE OR A COMBINATION OF BOTH RESULTING IN THE DEVICE BREACHING THE ANNULUS AND PERFORATING THE ILIAC ARTERY.

    Description of Event or Problem · 1

    PT WAS (B)(6) FEMALE, ABOUT (B)(6) WHO HAD SPONDYLOLISTHESIS ON L4/L5. SURGEON WAS DECOMPRESSING THE RIGHT SIDE FOLLOWING. BEFORE USING THE FLEX MIS DEVICE, THE SURGEON USED A 7MM SHAVER TO BREAK UP TISSUE. THE DEVICE WAS RUN FOR ABOUT 2.5 MINUTES IN THE STRAIGHT CONFIGURATION COLLECTING A LARGE AMOUNT OF MATERIAL AFTER WHICH THE DEVICE WAS ARTICULATED TO 200. MOMENTS LATER, THE ANESTHESIOLOGIST REPORTED THE PT WAS LOSING PRESSURE. SURGEON STOPPED THE DEVICE. HEAVY BLEEDING WAS NOTED AND ATTRIBUTED TO A PERFORATED ILIAC ARTERY. APPARENTLY THE DEVICE HAD ADVANCED THROUGH THE ANNULUS AND OUT INTO THE VESSEL CAUSING THE DAMAGE. PT WAS TURNED OVER AND GENERAL SURGERY UNIT WAS BROUGHT IN TO REPAIR THE DAMAGED VESSEL. PT WAS STABILIZED AND IS RECOVERING IN ICU. THE SURGEON REPORTED THAT HE WILL PUT IN AN INTERBODY DEVICE WHEN THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312492 ENSPIRE DEBRIDER, PRODUCT CODE: HRX HRX SPINE VIEW INC. 20120702-01FG

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R