BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOFIA FLOW PLUS 6F

    MDR report key: 11822560 · Received May 13, 2021

    Report

    Report Number
    2032493-2021-00175
    Event Type
    Death
    Date Received
    May 13, 2021
    Date of Event
    April 3, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MICROVENTION, INC
    Product Code
    NRY
    UDI-DI
    00812636020426
    PMA / PMN Number
    K173200
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SOFIA ASPIRATION CATHETER AND A PORTION OF THE THREAD-LIKE THROMBUS WERE RECEIVED FOR EVALUATION. DAMAGE WAS FOUND ALONG THE DISTAL END OF THE CATHETER AND KINKS WERE FOUND ALONG THE SHAFT. THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE COULD NOT BE IDENTIFIED, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE THREAD-LIKE MATERIAL WAS ANALYZED WITH FTIR AND FOUND TO BE GELATIN. GELATIN IS NOT USED DURING THE MANUFACTURING PROCESS OF THE CATHETER. THE SOURCE OF THE MATERIAL IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEATH AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THROMBECTOMY THE MICROCATHETER WAS ADVANCED WITH RESISTANCE DUE TO CERVICAL KINKING. THE MICROCATHETER WAS ADVANCED THROUGH THE SOFIA DURING THE SECOND MANEUVER, HOWEVER, RESISTANCE WAS AGAIN ENCOUNTERED DISTALLY. RECANALIZATION WAS ACHIEVED, BUT THERE WAS REMAINING OCCLUSION DISTALLY WITH COMPLETE CLOSURE OF THE VESSEL. THE SURGEON REPORTED A THREAD-LIKE, ELONGATED ELASTIC MATERIAL IN THE DISTAL ICA, WHICH HE DESCRIBED AS A THROMBUS. THE MATERIAL WAS INSPECTED BY THE HOSPITAL AND DETERMINED TO BE "ORGANIC," BUT ITS ORIGIN HAS NOT YET BEEN EVALUATED BY THE MANUFACTURER. IT WAS REPORTED THAT THE PATIENT LATER PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715222 SOFIA FLOW PLUS 6F CATHETER, THROMBUS RETRIEVER NRY MICROVENTION, INC DA6125ST 200728533 00812636020426

    Patients

    Seq Age Sex Outcome Treatment
    1 Death