BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 11354487 · Received February 19, 2021

    Report

    Report Number
    2015691-2021-01355
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 16, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103193961
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS TWO OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-01355. (MDR# 2021-02337-02).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. A REVIEW OF LOT HISTORY AND DEVICE HISTORY RECORD (DHR) REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE EVENT. DURING THE MANUFACTURING PROCESS, THE COMMANDER DELIVERY SYSTEM IS VISUALLY INSPECTED AND TESTED SEVERAL TIMES. DURING MANUFACTURING, THE DEVICE WAS 100% INSPECTED. DURING THE FINAL INSPECTION, THE DEVICE UNDERWENT 100% INSPECTION BY BOTH MANUFACTURING AND QUALITY. ADDITIONALLY, ALL MANUFACTURING LOTS ARE SUBJECT TO PRODUCT VERIFICATION (PV) TESTING ON A SAMPLING BASIS. ALL SAMPLES PASSED PRODUCT VERIFICATION TESTING FOR THIS LOT NUMBER. THESE INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT A NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORT THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE EVENT. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU)/TRAINING MATERIALS REVEALED NO DEFICIENCIES. PER THE PROCEDURAL TRAINING MANUALS: DO NOT OVERFLEX WHILE TRACKING OVER AORTIC ARCH. TO PREVENT KINKING OF THE DELIVERY SYSTEM, DO NOT TORQUE THE HANDLE WHILE ROTATING THE FLEX WHEEL. ENSURE THE EDWARDS LOGO FACES UPWARD THROUGHOUT FLEXING AND TRACKING. SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING EVALUATION, A PRODUCT RISK ASSESSMENT ESCALATION (PRA) IS NOT REQUIRED. PER THE COMPLAINT DESCRIPTION, "THERE WAS A KINK IN THE DELIVERY SYSTEM WHICH WAS CAUSED BY THE PATIENT'S ANATOMY. "NO DAMAGE WAS REPORTED ON THE PACKAGING OF THE DEVICE (I.E. SHIPPER BOX, SHELF BOX OR POUCH) OR DURING DEVICE PREPARATION. THE PROVIDED IMAGERY REVEALED THE PATIENT'S ACCESS VESSEL WAS UNDERSIZED AND CALCIFIED. ADDITIONALLY, THERE WAS A KINK IN THE PATIENT'S DESCENDING AORTA AND TORTUOSITY OBSERVED IN THE ARCH AND ASCENDING AORTA. CALCIFICATION AND TORTUOSITY IN THE ANATOMY MAY RESULT IN A KINKED DELIVERY SYSTEM. FURTHERMORE, THE CASE NOTES REVEALED THAT THE DEVICE WAS TORQUED TO OVERCOME TRACKING DIFFICULTIES THROUGH THE DESCENDING AORTA. EXCESSIVE MANIPULATION, SUCH AS TORQUEING, MAY ALSO RESULT IN A KINKED DELIVERY SYSTEM. SUBSEQUENTLY, A KINK IN THE DELIVERY SYSTEM CAN RESTRICT THE FLUID PATHWAY AND CAN CAUSE RESISTANCE EXPERIENCE DURING BALLOON INFLATION OR DEFLATION. IF THE BALLOON IS NOT FULLY INFLATED DUE TO A KINK IN THE DELIVERY SYSTEM, THE VALVE WOULD THEN BE UNDER-DEPLOYED POTENTIALLY CAUSING THE REPORTED EMBOLIZATION OF VALVE INTO THE VENTRICLE. ADDITIONALLY, IT IS POSSIBLE THAT PATIENT-RELATED FACTORS SUCH AS VESSEL TORTUOSITY MAY HAVE EXACERBATED THE INFLATION/DEFLATION DIFFICULTY. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING EVALUATION. WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR APPLICABLE IMAGERY, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. HOWEVER, AVAILABLE INFORMATION SUGGESTS THAT PATIENT (SEVERE AORTIC TORTUOSITY) AND PROCEDURAL FACTORS (EXCESSIVE MANIPULATION NAVIGATING TORTUOUS AORTA, KINKED DELIVERY SYSTEM) MAY HAVE CONTRIBUTED TO THE EVENT. NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. 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. THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION NOR PRA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS TWO OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED DURING A TAVR PROCEDURE WITH A 29MM S3 VALVE, THE OPERATOR WAS UNABLE TO FULLY DEPLOY THE VALVE DUE TO A SEVERE KINK IN THE DELIVERY SYSTEM THAT WAS CAUSED BY THE PATIENT'S ANATOMY. THE VALVE WAS UNDER EXPANDED CAUSING A CENTRAL LEAK AND EMBOLIZED INTO THE LEFT VENTRICLE. THE PATIENT WAS CONVERTED TO OPEN PROCEDURE TO REMOVE THE 29MM SAPIEN 3 VALVE AND PERFORM A SURGICAL AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245414 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS29A 63299096 00690103193961

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention