BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENOSURE BIOLOGIC PATCH

    MDR report key: 11753794 · Received April 30, 2021

    Report

    Report Number
    1220948-2021-00043
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    January 21, 2021
    Report Date
    April 29, 2021
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    PSQ
    PMA / PMN Number
    K190882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE PATCH FOR INVESTIGATION SINCE IT HAS BEEN DISCARDED BY THE USER. AT THIS TIME, WE COULD NOT CONFIRM IF THE BOVINE PATCH THAT WAS USED IN THE PROCEDURE WAS A XENOSURE BOVINE PATCH THAT ARE MANUFACTURED BY LEMAITRE VASCULAR, INC. THIS REPORT IS BEING SUBMITTED SINCE THE SALES REP. SUSPECT THE BOVINE PATCH TO BE A XENOSURE BOVINE PATCH SINCE THE SURGEON USES THESE PATCHES. DURING THE FOLLOW-UP INVESTIGATION, WE WERE INFORMED THAT THERE WERE NO ANY DAMAGE TO THE PACKAGING BOX. THE BLOOD CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. STAPHYLOCOCCUS AUREUS IS KNOWN TO BE HIGHLY SUSCEPTIBLE TO DESTRUCTION FROM OUR GLUTARALDEHYDE STERILIZATION PROCESS. FURTHER, OUR STUDIES HAVE SHOWN THAT THE HARDEST TO STERILIZE/REMOVE BACTERIA FOR OUR PROCESS ARE THE BACILLUS AND CLOSTRIDIUM STRAIN FOR WHICH WE HAVE CONDUCTED EXTENSIVE VALIDATION WORK TO PROVE EFFECTIVENESS OF THE STERILIZATION PROCESS. THESE FACTS INDICATE THAT THESE STRAINS COULD NOT SURVIVE THROUGH OUR STERILIZATION PROCESS OR STORAGE IN THE STORAGE SOLUTION AND INDICATES THAT THE SOURCE OF INFECTION IS SOME OTHER CAUSE. PLEASE NOTE THAT WE HAVE ALSO SUBMITTED MANUFACTURER REPORT NUMBER 1220948-2021-00044 RELATING TO OTHER CASE OF INFECTION THAT OCCURRED AT THE SAME HOSPITAL. WHILE THE ROOT CAUSE(S) OF THIS INCIDENT REMAINS INCONCLUSIVE, WE DO BELIEVE THAT IT IS HIGHLY UNLIKELY THAT THE XENOSURE PATCH CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    THE SURGEON INFORMED SALES REP. THAT TWO OF HIS PATIENTS WHO HAD A BOVINE PATCH IMPLANT NEEDED RE-INTERVENTION. THE SURGEON HOWEVER DOES NOT EXPLICITLY MENTION THEY WERE THE XENOSURE BOVINE PATCHES THAT WERE USED IN THE PROCEDURES. THIS IS REPORT 1 OF 2. THE PATIENT HAD A RIGHT FEMORAL PSEUDOANEURYM REQUIRING CFA AND PREVIOUS PATCH EXCISION. THE REPAIR WAS COMPLETED WITH ARTEGRAFT INTERPOSITION. BLOOD CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651862 XENOSURE BIOLOGIC PATCH INTRACARDIAC PATCH OR PLEDGET PSQ LEMAITRE VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention