BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW VALSALVA CONDUIT

    MDR report key: 8072083 · Received November 14, 2018

    Report

    Report Number
    3005687633-2018-00211
    Event Type
    Injury
    Date Received
    November 14, 2018
    Report Date
    December 10, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE ON NOV. 15, 2018. THE FOLLOWING UPDATED EVENT DESCRIPTION HAS BEEN INCLUDED. A PATIENT WAS SCHEDULED FOR A PROCEDURE. THE PHYSICIAN WAS USING A MITROFLOW VALSALVA CONDUIT FOR THE FIRST TIME. THE PHYSICIAN CUT THE MVC ON THE VALSALVA TO USE THE CONDUIT LIKE A STANDARD CONDUIT. ONLY THE CONDUIT WAS USED AND NO VALVE WAS INVOLVED. IT WAS REPORTED THERE WAS A FOREIGN OBJECT, POTENTIALLY A PART OF THE ACCESSORY, LEFT IN THE PATIENT. THE PATIENT DEVELOPED A FEVER. THE SITE REPORTED THEY DO NOT KNOW THE SOURCE OF THE FEVER. THE OUTCOME OF THE PATIENT IS UNKNOWN. INFORMATION REGARDING ANY RE-OPERATIONS IS UNKNOWN. THE SERIAL NUMBER, DEVICE MODEL AND CATALOG NUMBER ARE UNAVAILABLE. THE DEVICE IS NOT AVAILABLE, THE SERIAL NUMBER, MODEL NUMBER, AND CATALOG NUMBER ARE ALL UNKNOWN. BASED ON THIS THERE ARE NO INVESTIGATIONS POSSIBLE AT THE PRESENT TIME. THE MANUFACTURE FOLLOWED UP FOR ADDITIONAL INFORMATION AND NO FURTHER DETAILS WERE AVAILABLE OTHER THAN THE INFORMATION INCLUDED IN THE EVENT SUMMARY. BASED ON THIS NO INVESTIGATIONS HAVE BEEN PERFORMED AND THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED THE MANUFACTURER WILL PERFORM ANY POSSIBLE INVESTIGATIONS BASED ON THE RECEIVED INFORMATION AND WILL UPDATE THE COMPETENT AUTHORITIES ACCORDINGLY.

    Description of Event or Problem · 0

    A PATIENT WAS SCHEDULED FOR A PROCEDURE. THE PHYSICIAN WAS USING A MITROFLOW VALSALVA CONDUIT FOR THE FIRST TIME. THE PHYSICIAN CUT THE MVC ON THE VALSALVA TO USE THE CONDUIT LIKE A STANDARD CONDUIT. ONLY THE CONDUIT WAS USED AND NO VALVE WAS INVOLVED. IT WAS REPORTED THERE WAS A FOREIGN OBJECT, POTENTIALLY A PART OF THE ACCESSORY, LEFT IN THE PATIENT. THE PATIENT DEVELOPED A FEVER. THE SITE REPORTED THEY DO NOT KNOW THE SOURCE OF THE FEVER. THE OUTCOME OF THE PATIENT IS UNKNOWN. INFORMATION REGARDING ANY RE-OPERATIONS IS UNKNOWN. THE SERIAL NUMBER, DEVICE MODEL AND CATALOG NUMBER ARE UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    A PATIENT WAS SCHEDULED FOR A PROCEDURE. THE PHYSICIAN WAS USING A MITROFLOW VALSALVA CONDUIT FOR THE FIRST TIME. THE PHYSICIAN CUT THE MVC ON THE VALSALVA TO USE THE CONDUIT LIKE A STANDARD CONDUIT. IT WAS REPORTED THERE WAS A FOREIGN OBJECT, POTENTIALLY A PART OF THE ACCESSORY, LEFT IN THE PATIENT. THE PATIENT DEVELOPED A FEVER. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908519 MITROFLOW VALSALVA CONDUIT TISSUE HEART VALVE LWR SORIN GROUP ITALIA S.R.L. TBD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other