BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENOSURE BIOLOGIC PATCH

    MDR report key: 11753793 · Received April 30, 2021

    Report

    Report Number
    1220948-2021-00044
    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 SALES REP. HAS ATTEMPTED MULTIPLE TIMES TO GET ADDITIONAL INFORMATION RELATING TO THIS CASE. NO FURTHER INFORMATION WAS PROVIDED DESPITE HER REPEATED ATTEMPTS. PLEASE NOTE THAT WE HAVE ALSO SUBMITTED MANUFACTURER REPORT NUMBER 1220948-2021-00045 RELATING TO OTHER CASE OF INFECTION THAT OCCURED 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 2 OF 2. NO FURTHER INFORMATION WAS PROVIDED RELATING TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651861 XENOSURE BIOLOGIC PATCH INTRACARDIAC PATCH OR PLEDGET PSQ LEMAITRE VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention