BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRO

    MDR report key: 3804459 · Received April 29, 2014

    Report

    Report Number
    3004672932-2014-00004
    Event Type
    Death
    Date Received
    April 29, 2014
    Date of Event
    June 13, 2013
    Report Date
    April 29, 2014
    Manufacturer
    ONSET MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K100819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS CONDUCTED BASED ON A REVIEW OF THE INFO PROVIDED BY THE USER FACILITY AND MANUFACTURING QUALITY RECORDS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THERE WAS NO PRODUCTION RELATED PROBLEMS. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION PROVIDED BY THE USER FACILITY INDICATED THAT THE EVENT MAY HAVE BEEN RELATED TO AN OVERSIZED SHEATH IN CONJUNCTION WITH A CALCIFIED VESSEL. IN THIS CASE, THE PHYSICIAN CHOSE A 21 FR SOLOPATH DEVICE (WHICH HAS AN EXPANDED SHEATH OUTER DIAMETER OF 8MM) USED IN A 4MM VESSEL WITH CALCIFICATION. LIMITED BY THE VESSEL MORPHOLOGY, THE SHEATH WAS NOT ABLE TO REACH FULL EXPANSION RESULTING IN THE STENT GETTING WEDGED/STUCK IN THE UNEXPANDED AREA. WHEN THE PHYSICIAN PULLED BACK ON THE SHEATH FOR A SECOND TIME WITH THE STENT LODGED IN THE SHEATH, THE ARTERY MAY HAVE BEEN EXPOSED OR AVULSED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN AVULSION OF THE ARTERY OCCURRED DURING A PROCEDURE. FOLLOW-UP COMMUNICATION CONFIRMED THAT : THE DEVICE WAS INSERTED AND EXPANDED IN THE PT WITHOUT ISSUE; THE PHYSICIAN THEN ATTEMPTED TO INSERT AND MULTILAYER STENT, BUT THE DEVICE WOULD NOT ADVANCE THROUGH THE SOLOPATH; THE STENT WAS REMOVED AND THE SOLOPATH WAS EXPANDED A SECOND TIME; ANOTHER ATTEMPT WAS THEN MADE TO PLACE THE STENT, WITHOUT SUCCESS; SUBSEQUENTLY, THE STENT BECAME STUCK IN THE INTRODUCER, WHICH PREVENTED THE SOLOPATH FROM RETRACTING; THE SOLOPATH AND STENT WERE THEN REMOVED TOGETHER CAUSING THE INNER LAYER OF THE ILIAC ARTERY TO TEAR, LEADING TO THE PT'S DEATH; AND THE PHYSICIAN OPENED THE ARTERY TO REMOVE THE DEVICE AND NOTED THAT IT HAD NOT ADVANCED PAST A CALCIFIED PORTION OF THE VESSEL WHICH HAD CAUSED THE DEVICE TO BECOME TRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256970 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRO INTRODUCER DYB ONSET MEDICAL CORPORATION STFI-2125 W034851

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death STENT MULTILAYER 18FR