BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 23000232 · Received September 9, 2025

    Report

    Report Number
    2015691-2025-07386
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    March 13, 2025
    Report Date
    October 9, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    UDI-DI
    00690103211597
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS 2 OF 2 REPORTS. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ENGINEERING EVALUATION FINDINGS, SECTIONS G6, H2, H6: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS AND H11 HAS BEEN ADDED. THE EVENT(S) REPORTED IS/ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODE(S) IS NOT REQUIRED AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR EVALUATION. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THE INSTRUCTIONS FOR USE (IFU), TRAINING MANUALS AND CURRENT RISK MITIGATIONS HAVE BEEN REVIEWED. NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE COMPLAINT FOR INFLATION DIFFICULTY AND/OR INCOMPLETE INFLATION IS CONFIRMED BASED ON REVIEW OF THE PROVIDED IMAGERY. AS THE DEVICE WAS NOT RETURNED, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL EXAMINATION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THEREFORE, THE PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DHR AND LOT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. FURTHERMORE, NO ABNORMALITIES WERE REPORTED DURING DEVICE UNPACKING OR PREPARATION. AS REPORTED, 'IT WAS DEEMED THAT SEPARATION OF THE SHEATH TIP OCCURRED, LEADING TO BALLOON INFLATION DIFFICULTY OF THE DELIVERY SYSTEM. ['] THERE WAS RESISTANCE WHEN THE CRIMPED VALVE ON THE DELIVERY SYSTEM WAS EXITING THE DISTAL END OF THE SHEATH. DURING VALVE DEPLOYMENT, THE DISTAL BALLOON DID NOT EXPAND INITIALLY BUT THEN SUDDENLY EXPANDED IN A BURST-LIKE MANNER. THE VALVE WAS DEPLOYED WITHOUT ANY ISSUES.' WHILE THERE WAS NO EVIDENCE INDICATING THAT A MANUFACTURING NON-CONFORMANCE MAY HAVE CONTRIBUTED TO THE COMPLAINT, THE INVESTIGATION SHOWS THAT THE REPORTED EVENT MAY BE RELATED TO DEVICE INTERACTIONS, CAUSED BY A CIRCUMFERENTIAL TEAR AT THE SHEATH'S DISTAL TIP. THIS TEAR COULD LODGE ONTO THE DISTAL END OF THE VALVE, PREVENTING IT FROM DEPLOYING EVENLY. ADDITIONALLY, ALTHOUGH THE SHEATH WAS NOT RETURNED FOR EVALUATION, SHEATH DISTAL TIP SEPARATION WAS REPORTED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS JAPANESE AFFILIATE, IT WAS DEEMED THAT SEPARATION OF THE SHEATH TIP OCCURRED, LEADING TO BALLOON INFLATION DIFFICULTY OF THE DELIVERY SYSTEM. A TRANSFEMORAL TAVR PROCEDURE WAS PERFORMED FOR THE NATIVE AORTIC VALVE, AND A DELIVERY SYSTEM WITH A 26 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE WAS INSERTED INTO A 14 FR ESHEATH+. THERE WAS RESISTANCE WHEN THE CRIMPED VALVE ON THE DELIVERY SYSTEM WAS EXITING THE DISTAL END OF THE SHEATH. DURING VALVE DEPLOYMENT, THE DISTAL BALLOON DID NOT EXPAND INITIALLY BUT THEN SUDDENLY EXPANDED IN A BURST-LIKE MANNER. THE VALVE WAS DEPLOYED WITHOUT ANY ISSUES. THERE WAS NO SYMPTOM POST-OPERATIVE COURSE, AND THE PATIENT WAS DISCHARGED. PER MEDICAL OPINION, THE CAUSE OF THE DELAYED DISTAL BALLOON EXPANSION WAS UNKNOWN AT THAT TIME. THE FLUOROSCOPIC IMAGE WAS RE-REVIEWED; SINCE A TRANSPARENT SHEATH-LIKE FRAGMENT WAS SEEN AT THE DISTAL END OF THE CRIMPED VALVE STENT, IT WAS DEEMED THAT SEPARATION OF THE SHEATH TIP OCCURRED AND ATTACHED AT THE DISTAL END OF THE CRIMPED VALVE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496540 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9750CM26J 66049102 00690103211597

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male