BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIXENE SLIDER GDS

    MDR report key: 24618305 · Received March 17, 2026

    Report

    Report Number
    3011175548-2026-000002
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    DSY
    UDI-DI
    00650862251418
    PMA / PMN Number
    K071923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED COMPLAINT REGARDING THE FIRST CLOT IDENTIFIED ON 30 JAN 2026. MFG REPORT NUMBER: 3011175548-2026-0000023. DUE TO CHARACTER LIMITATIONS IN FIELD E1: INITIAL REPORTER: (B)(6). UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT A GRAFT THROMBOSIS AND RE OCCLUSION OCCURRED AFTER IMPLANTATION OF A FLIXENE EPTFE VASCULAR GRAFT (MODEL 25141, LOT 524685). THE DEVICE WAS IMPLANTED AS AN ARTERIOVENOUS (AV) ACCESS GRAFT. APPROXIMATELY 17 DAYS POST IMPLANT, THE GRAFT WAS OBSERVED TO BE OCCLUDED DUE TO CLOT FORMATION; THE GRAFT HAD NOT BEEN CANNULATED, AND NO PATIENT INJURY WAS REPORTED. THE CLOT WAS SURGICALLY CLEARED, AND THE GRAFT REMAINED IMPLANTED. A SUBSEQUENT FOLLOW UP VISIT IDENTIFIED RE OCCLUSION OF THE GRAFT, CONFIRMED BY CLINICAL EXAMINATION AND ULTRASOUND. ADDITIONAL INTERVENTION IN THE FORM OF THROMBECTOMY WAS REQUIRED. THE PATIENT IS A 90 YEAR OLD FEMALE WITH DECLINING RENAL FUNCTION AND A MEDICAL HISTORY SIGNIFICANT FOR DIABETES, HYPERTENSION, AND HYPERLIPIDEMIA. THE PATIENT HAD NOT INITIATED DIALYSIS AT THE TIME OF THE EVENTS. POSTOPERATIVE ANTICOAGULATION THERAPY WAS LIMITED TO 81 MG ASPIRIN, WITH NO ADDITIONAL ANTIPLATELET OR ANTICOAGULANT THERAPY PRESCRIBED DUE TO CONCERNS RELATED TO FALL RISK. INTRAOPERATIVE HEPARIN WAS ADMINISTERED DURING BOTH THE INITIAL IMPLANTATION AND SUBSEQUENT THROMBECTOMY PROCEDURES. GETINGE MEDICAL AFFAIRS CONTACTED THE REPORTING PHYSICIAN TO OBTAIN ADDITIONAL CLINICAL INFORMATION. THE PHYSICIAN REPORTED THAT IMPLANTATION WAS PERFORMED WITHOUT COMPLICATION, WITH APPROPRIATE ANTEGRADE BLEEDING AND NO OBSERVED INFLOW OR OUTFLOW ABNORMALITIES. THE REPORTING PHYSICIAN STATED THAT NO DEVICE RELATED ISSUES WERE IDENTIFIED DURING IMPLANTATION AND DID NOT ATTRIBUTE THE THROMBOTIC EVENTS TO THE FLIXENE GRAFT, NOTING THAT THROMBOSIS OF UNKNOWN ETIOLOGY CAN OCCUR IN VASCULAR ACCESS PROCEDURES. THE PHYSICIAN INDICATED THE PATIENT MAY HAVE AN UNDERLYING CLOTTING DISORDER, WHICH IS PLANNED FOR FURTHER EVALUATION. THE DEVICE WAS NOT RETURNED, AND NO IMAGES WERE PROVIDED; THEREFORE, CONFIRMATORY DEVICE TESTING COULD NOT BE PERFORMED, AND THE COMPLAINT COULD NOT BE CONFIRMED. DUE TO THE INABILITY TO REPRODUCE THE EVENT AND THE PRESENCE OF SIGNIFICANT PATIENT COMORBIDITIES, A CONTEMPORANEOUS SAMPLE WAS NOT REQUESTED. A REVIEW OF THE DEVICE HISTORY RECORD, INCLUDING FINISHED GOODS AND TOP ASSEMBLY RECORDS, IDENTIFIED NO MANUFACTURING NONCONFORMANCES. ALL REVIEWED RECORDS MET APPLICABLE QUALITY AND PERFORMANCE REQUIREMENTS. A REVIEW OF PRODUCT SPECIFICATIONS AND ENGINEERING CHANGE HISTORY DID NOT IDENTIFY ANY DESIGN CHANGES RELEVANT TO THE REPORTED EVENT. TREND ANALYSIS COVERING A 15 MONTH PERIOD IDENTIFIED A LOW NUMBER OF SIMILAR COMPLAINTS. WHILE A STATISTICAL EXCURSION WAS IDENTIFIED, THE ACTUAL OCCURRENCE LEVEL DID NOT EXCEED THE ANTICIPATED OCCURRENCE LEVEL, AND ESCALATION WAS PERFORMED IN ACCORDANCE WITH THE APPLICABLE COMPLAINT TRENDING PROCEDURE. REVIEWS OF CAPA, NCR, AND SCAR SYSTEMS IDENTIFIED NO RELATED ISSUES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE WAS DETERMINED TO BE USER ¿ ANTICIPATED PROCEDURAL COMPLICATION, AS THROMBOSIS IS A KNOWN ADVERSE EVENT ASSOCIATED WITH VASCULAR GRAFTS AND IS ADEQUATELY ADDRESSED IN THE PRODUCT RISK MANAGEMENT DOCUMENTATION AND INSTRUCTIONS FOR USE. THE EVENT IS MOST LIKELY ATTRIBUTABLE TO PATIENT SPECIFIC FACTORS, INCLUDING COMORBIDITIES AND LACK OF POSTOPERATIVE ANTICOAGULATION, RATHER THAN DEVICE DESIGN, MANUFACTURING, OR MATERIAL ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLIXENE GRAFT REOCCLUDED AGAIN DURING ASSESSMENT AFTER IT HAD BEEN SUCCESSFULLY CLEARED BY THE SURGEON. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414972 FLIXENE SLIDER GDS PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY ATRIUM MEDICAL CORPORATION 25141 524685 00650862251418

    Patients

    Seq Age Sex Outcome Treatment
    1