BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED AXILLO BIFEMORAL

    MDR report key: 24604559 · Received March 16, 2026

    Report

    Report Number
    2242352-2026-00004
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 4, 2022
    Report Date
    May 22, 2026
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401015109
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (4117) THE DEVICE IS NOT AVAILABLE FOR EVALUATION. BASED ON AVAILABLE INFORMATION, THE IMPLANTED GRAFT REMAINS IN SITU AND WAS NOT EXPLANTED. THEREFORE, NO PHYSICAL DEVICE ANALYSIS CAN BE PERFORMED. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 15M24. (3331/3233) THE DEVICE HISTORY RECORDS REVIEW IS ONGOING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY ON APRIL 4, 2017, THE PATIENT WITH AORTIC OCCLUSIVE DISEASE IN THE ILIAC REGION HAD 100 PERCENT PRE-PROCEDURE STENOSIS. AN INTERGARD STANDARD AXILLO BIFEMORAL GRAFT WAS IMPLANTED, AN ILIAC STENT WAS ALSO IMPLANTED. DURING THIS PROCEDURE SUTURE HOLE BLEEDING OCCURRED AND A LOCAL HEMOSTATIC AGENT (TYPE UNKNOWN) WAS USED TO ARREST THE BLEEDING. TECHNICAL SUCCESS WAS ACHIEVED, AND THE PATIENT WAS DISCHARGED ON APRIL 18, 2017 ON MAY 28, 2017, 54 DAYS AFTER THE INITIAL IMPLANT, THE PATIENT EXPERIENCED THROMBOSIS OF THE CROSSED BRANCH OF THE AXILLO-BIFEMORAL BYPASS. THE SEVERITY WAS NOTED AS MODERATE AND THE INVESTIGATOR NOTED THIS WAS POSSIBLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. ON FEBRUARY 4TH, 2022, 4 YEARS, 10 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE THE PATIENT EXPERIENCED PERIPROSTHETIC COLLECTION. THREE SEPARATE COMPLAINTS WERE CREATED FOR THESE THREE EVENTS. ACCORDINGLY, THREE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED FOR EACH EVENT. THIS REPORT IS THE THIRD IN A SERIES OF THREE REPORTS SUBMITTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266555 HEMAGARD KNITTED AXILLO BIFEMORAL PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS HGKAX0808 15M24 00384401015109

    Patients

    Seq Age Sex Outcome Treatment
    1