BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALBOGRAFT POLYESTER VASCULAR GRAFT

    MDR report key: 10795871 · Received November 5, 2020

    Report

    Report Number
    1220948-2020-00107
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 5, 2020
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MAL
    UDI-DI
    00840663102822
    PMA / PMN Number
    K093231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT PERFORM A HANDS-ON EVALUATION ON THE GRAFT SINCE IT HAS BEEN DISCARDED BY THE USER FACILITY. WE HAVE SENT A LIST OF FOLLOW-]UP QUESTIONS TO THE HOSPITAL BUT HAVE NOT YET RECEIVED A RESPONSE DESPITE OUR REPEATED ATTEMPTS. THE INVESTIGATION IS ONGOING, BUT OUR INQUIRIES ARE NOT GETTING ANY MORE RESPONSE DUE TO THE INCREASING COVID-19 SITUATION IN EUROPE. WE HAVE RELEASED A TOTAL OF (B)(4) UNITS OF ALBOGRAFT VASCULAR GRAFT FROM THIS LOT NUMBER. THIS GRAFT CATALOG# AMC6006; LOT# 211047 SERIAL# (B)(4) WAS SOLD TO THE HOSPITAL ON (B)(6) 2018. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS RELATED TO A SIMILAR INCIDENT FOR THIS LOT NUMBER. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS GRAFT DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. WE HAVE ALSO REVIEWED OUR COMPLAINT HISTORY FOR LAST 5 YEARS. WE DID NOT FIND ANY OTHER COMPLAINTS RELATED TO A SIMILAR ISSUE REPORTED TO US BY OTHER HOSPITALS. PLEASE ALSO REFER TO MANUFACTURER INCIDENT REPORT# 1220948-2020-00106 RELATING TO ANOTHER CASE OF THROMBOSIS THAT OCCURRED AT THE SAME HOSPITAL AFTER IMPLANTING ALBOGRAFT VASCULAR GRAFT. WE HAVE RECEIVED A TOTAL OF (B)(4) COMPLAINTS FROM THIS HOSPITAL ON THE SAME DAY FOR THIS ISSUE WITH THE SAME EXACT DESCRIPTION WHICH RAISES QUESTIONS ON HOW THESE GRAFTS WERE PREPARED AND IMPLANTED, INCLUDING ANY POSTOPERATIVE CARE PROVIDED TO THE PATIENTS. WE HAVE ALSO REVIEWED OUR RISK DOCUMENT. THE CURRENT RATE OF OCCURRENCE FOR THIS ISSUE IS WITHIN OUR EXPECTED RATE. OUR IFU MENTIONS A LIST OF POTENTIAL COMPLICATIONS INCLUDING THROMBOSIS THAT OCCUR WITH THE USE OF ALBOGRAFT VASCULAR GRAFT.

    Description of Event or Problem · 1

    PROSTHESIS THROMBOSIS. FEM-POP ARTERIAL BYPASS. NEED OF ANOTHER SURGERY TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256848 ALBOGRAFT POLYESTER VASCULAR GRAFT VASCULAR PROSTHESIS MAL LEMAITRE VASCULAR, INC. AMC3006 211047 00840663102822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention