BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 20007623 · Received August 20, 2024

    Report

    Report Number
    2015691-2024-06288
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 27, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103211580
    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

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ENGINEERING EVALUATION FINDINGS. SECTIONS B4, G3, G6, H2, H6: COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED. THE EVENT REPORTED IS ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODES 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 IFU AND TRAINING MANUALS HAVE BEEN REVIEWED, NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. IMAGING WAS PROVIDED AND REVEALED THAT PRIOR TO DEPLOYMENT, THE CRIMPED VALVE APPEARED TO NOT BE BETWEEN THE VALVE ALIGNMENT MARKERS. THE SEQUENCE OF THE VALVE DEPLOYMENT WAS AS FOLLOWS: VALVE INFLOW WAS NOT FULLY EXPANDED ON THE DISTAL INFLATION BALLOON SIDE, BALLOON WAS DEFLATED, AND VALVE WAS FULLY EXPANDED AFTER INFLATING THE BALLOON AGAIN. IN THIS CASE, THE COMPLAINT OF INCOMPLETE INFLATION WAS CONFIRMED BASED ON THE PROVIDED PROCEDURAL IMAGERY. AN ADDITIONAL COMPLAINT OF VALVE NOT BETWEEN ALIGNMENT MARKERS AND DEPLOYED WAS ALSO DISCOVERED PER THE PROVIDED IMAGERY. WHILE THERE WAS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT OF INCOMPLETE INFLATION, INVESTIGATION SHOWS THAT THE REPORTED EVENT MAY BE RELATED TO DEVICE INTERACTIONS CAUSED BY A POTENTIAL CIRCUMFERENTIAL TEAR AT THE SHEATH'S DISTAL TIP. THIS TEAR COULD LODGE ONTO THE DISTAL END OF THE VALVE, PREVENTING IT FROM DEPLOYING EVENLY. DURING FOLLOW-UP, THE FIELD RESPONDED THAT THERE WAS NO DAMAGE AT THE SHEATH'S DISTAL TIP UPON REMOVAL. HOWEVER, SINCE A CIRCUMFERENTIAL TEAR IS LESS VISUALLY OBVIOUS COMPARED TO A PARTIAL TEAR AND THERE IS NO PHYSICAL EVIDENCE (E.G., DEVICE, IMAGERY) TO CONFIRM THE RESPONSE, EDWARDS RETAINED DEVICE INTERACTIONS AS SUGGESTED ABOVE AS A POSSIBLE FACTOR. WHILE THERE WAS NO REPORT OF VALVE ALIGNMENT DIFFICULTY, IMAGERY REVIEW SHOWED THAT THE VALVE WAS NOT PROPERLY ALIGNED IN BETWEEN THE VALVE ALIGNMENT MARKERS PRIOR TO DEPLOYMENT. PER TRAINING MANUAL, ''BEFORE DEPLOYMENT, ENSURE THAT THE THV IS CORRECTLY POSITIONED BETWEEN THE VALVE ALIGNMENT MARKERS AND THE FLEX CATHETER TIP IS OVER THE TRIPLE MARKER''. DESPITE THE VALVE NOT BEING ALIGNED BETWEEN THE MARKERS, THE USER DECIDED TO DEPLOY THE VALVE. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT USE ERROR (NOT FOLLOW INSTRUCTIONS) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. TO FURTHER INVESTIGATE AND ASSESS THE POTENTIAL RISK ASSOCIATED WITH THE INCOMPLETE INFLATION ISSUE, A PRA AND CAPA DETERMINATION HAVE BEEN INITIATED.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFESCIENCES JAPANESE AFFILIATE, THE PATIENT UNDERWENT A RIGHT-SIDE TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC POSITION. DURING VALVE DEPLOYMENT, THE VALVE ON THE LEFT VENTRICULAR SIDE DID NOT EXPAND AND WAS ALMOST ABOUT TO MIGRATE. THE BALLOON OF THE COMMANDER DELIVERY SYSTEM WAS DEFLATED MIDWAY AND THE DELIVERY SYSTEM PUSHED TO THE AORTIC SIDE. THE BALLOON WAS INFLATED AGAIN AND THE VALVE SUCCESSFULLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152222 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23J 65571967 00690103211580

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female