BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE

    MDR report key: 10192145 · Received June 24, 2020

    Report

    Report Number
    2134265-2020-07950
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    October 16, 2019
    Report Date
    June 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    UDI-DI
    08714729960911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED 01 JUNE 2020. IT WAS REPORTED THAT THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS FROZE ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA TRANSFEMORAL APPROACH. A SAFARI2 GUIDE WIRE WAS POSITIONED. A 25MM LOTUS EDGE VALVE DELIVERY SYSTEM WAS ADVANCED OVER THE SAFARI2 GUIDE WIRE AND THE 25MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED. DURING REMOVAL OF THE LOTUS EDGE DELIVERY SYSTEM, THE SAFARI2 GUIDE WIRE BECAME LOCKED UP INSIDE THE LOTUS EDGE DELIVERY SYSTEM. THE LOTUS EDGE DELIVERY SYSTEM WAS ABLE TO BE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT UNPLANNED VASCULAR SURGERY OR INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653349 LOTUS EDGE VALVE LOTUS EDGE TM VALVE SYSTEM 25 MM NPT BOSTON SCIENTIFIC CORPORATION H749LVSUS250 0023810554 08714729960911

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention