BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRO

    MDR report key: 2842391 · Received November 14, 2012

    Report

    Report Number
    3004672932-2012-00005
    Event Type
    Death
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ONSET MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K092014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED: "PHYSICIAN WAS TREATING A PT WHO PRESENTED WITH A CHALLENGING AAA. THE PHYSICIAN DECIDED TO USE SOLOPATH TO ASSIST DELIVERING THE ENDOLOGIX AAA DEVICE IN ORDER TO TREAT THE PT. ACCESS WAS GAINED IN THE LEFT GROIN WITH STANDARD FEMORAL SHEATH AND WIRE FOLLOWED BY THE INSERTION OF THE SOLOPATH DEVICE. THE PT HAD HEAVILY DISEASED CALCIFIED ANATOMY THROUGHOUT THE EXTERNAL AND COMMON ILIACS. ONCE THE SOLOPATH WAS POSITIONED PROPERLY THE PHYSICIAN PROCEEDING THE INFLATE SOLOPATH TO 20ATM FOR ONE MINUTE. AT THAT TIME THE SOLOPATH BALLOON WAS DEFLATED AND THE DILATOR WAS REMOVED. NEXT THE ENDOLOGIX DELIVERY SYSTEM WAS INSERTED INTO SOLOPATH. AS THE DOCTOR POSITIONED THE AAA DEVICE IN THE PT'S BODY TO BE DEPLOYED HE NOTICED THE SOLOPATH SHEATH WAS ADVANCED TOO FAR AND WOULD RESTRICT THE DEPLOYMENT OF THE AAA DEVICE. AS THE PHYSICIAN ATTEMPTED TO PULL BACK THE SOLOPATH SHEATH HE NOTICED THE SHEATH WAS STUCK OR RESISTED BEING PULLED BACK DISTALLY INTO THE COMMON ILIAC. FINALLY, HE WAS ABLE TO PULL BACK THE SHEATH BUT NOTICED THERE WAS A RUPTURE TO THE COMMON ILIAC OF THE PT. AT THAT TIME HE NEEDED TO EMERGENTLY CONVERT TO AN OPEN AAA. THE PT CRASHED, CODED, AND SOON THEREAFTER EXPIRED." ADDITIONAL DETAILS RECEIVED (B)(6) 2012: "LEFT GROIN CUT DOWN COMPLETED BY PHYSICIAN. ACCESS WAS GAINED IN THE LEFT COMMON ILIAC, PHYSICIAN PLANNED TO DELIVER MAIN BODY AAA DEVICE (ENDOLOGIX). ENDOLOGIX DEVICE WAS INSERTED OVER THE WIRE AND WAS ATTEMPTED TO BE PASSED INTO POSITION IN THE AORTA FOR DELIVERY. THE AAA DEVICE WAS NOT ABLE TO PASS THROUGH ILIAC SYSTEM. PHYSICIAN REMOVED ENDOLOGIX DELIVERY SYSTEM AND INSERTED SOLOPATH OVER THE WIRE. SOLOPATH WAS POSITIONED IN PT AND INFLATED PROPERLY. DILATOR SYSTEM OF SOLOPATH WAS REMOVED AND ENDOLOGIX DELIVERY SYSTEM WAS INSERTED THROUGH SOLOPATH. THE PHYSICIAN NOTICED THAT SOLOPATH WAS ADVANCED TOO FAR IN TO PT'S ANATOMY TO FULLY DEPLOY THE AAA GRAFT. IN ORDER TO PROPERLY DEPLOY THE AAA DEVICE PHYSICIAN ATTEMPTED TO PULL BACK SOLOPATH, AS THE PHYSICIAN ATTEMPTED TO PULL BACK THE SOLOPATH SHEATH HE NOTICED THE SHEATH WAS STUCK OR RESISTED BEING PULLED BACK DISTALLY INTO THE COMMON ILIAC. FINALLY, HE WAS ABLE TO PULL BACK THE SHEATH BUT NOTICED THERE WAS A RUPTURE TO THE COMMON ILIAC OF THE PT. AT SOME POINT SHORTLY AFTER THE RUPTURE THE WIRE THAT WAS POSITIONED IN THE AORTA WAS PULLED BACK INTO THE SHEATH AND WITH THAT THERE WAS NOT AN OPTION TO TRY AND SALVAGE THE CASE FROM AN ENDOVASCULAR APPROACH. AT THAT TIME HE NEEDED TO EMERGENTLY CONVERT TO AN OPEN AAA. PT CRASHED AND CODED VERY QUICKLY AND EXPIRED SOON THEREAFTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRO INTRODUCER DYB ONSET MEDICAL CORPORATION STFI-2125 W034656

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death