BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS M COMMANDER DELIVERY SYSTEM

    MDR report key: 14412196 · Received May 16, 2022

    Report

    Report Number
    2015691-2022-05719
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 15, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103214321
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES. HOWEVER; IS DEEMED SIMILAR TO THE EDWARDS COMMANDER DELIVERY SYSTEM, PMA P140031. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ADDED H.6 TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS. CORRECTED H.6 INVESTIGATION CONCLUSIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. DURING MANUFACTURING OF THE COMMANDER M DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. THE IFU, DEVICE PREPARATION MANUAL, AND PROCEDURAL TRAINING MANUAL WERE REVIEWED. DURING DEVICE PREPARATION, ATTACH A HIGH PRESSURE 3-WAY STOPCOCK TO THE BALLOON INFLATION PORT. PARTIALLY FILL A 60 CC OR LARGER SYRINGE WITH 15-20 ML DILUTED CONTRAST MEDIUM AND ATTACH TO THE 3-WAY STOPCOCK. FILL THE PROVIDED INFLATION DEVICE WITH EXCESS VOLUME OF DILUTED CONTRAST SOLUTION RELATIVE TO THE INDICATED INFLATION VOLUME. LOCK THE INFLATION DEVICE AND ATTACH TO THE 3-WAY STOPCOCK. CLOSE THE 3-WAY STOPCOCK TO THE INFLATION DEVICE AND FULLY DE-AIR THE BALLOON USING THE 60 CC OR LARGER SYRINGE. SLOWLY RELEASE THE PLUNGER AND LEAVE ZERO-PRESSURE IN THE SYSTEM. ENSURE THERE IS NO RESIDUAL FLUID LEFT IN THE BALLOON TO AVOID POTENTIAL DIFFICULTY WITH VALVE ALIGNMENT. CLOSE THE STOPCOCK TO THE DELIVERY SYSTEM AND DE-AIR INFLATION DEVICE. ENSURE THE APPROPRIATE VOLUME REQUIRED TO DEPLOY THE VALVE IS IN THE INFLATION DEVICE. CLOSE THE STOPCOCK TO THE 60 CC OR LARGER SYRINGE. REMOVE THE SYRINGE. ENSURE INFLATION DEVICE IS IN THE LOCKED POSITION UNTIL THV DEPLOYMENT. INSERT CRIMPED VALVE AND LOADER FULLY INTO THE GUIDE SHEATH. TO PREVENT POSSIBLE LEAFLET DAMAGE, THE VALVE SHOULD NOT REMAIN IN THE SHEATH FOR OVER 5 MINUTES. ASPIRATE AND FLUSH GUIDE SHEATH. ATTACH 60CC SYRINGE WITH > 40 ML HEPARINIZED SALINE - LEAVE STOPCOCK OPEN TO GUIDE SHEATH. FAILURE TO ATTACH THE 60CC SYRINGE WITH > 40ML HEPARINIZED SALINE TO THE EDWARDS GUIDE SHEATH AND LEAVE THE STOPCOCK OPEN TO THE SYRINGE CAN INTRODUCE AIR INTO THE LEFT ATRIUM. ADVANCE CRIMPED VALVE OUT OF LOADER. WITHDRAW AND PEEL AWAY LOADER. ADVANCE THE CRIMPED VALVE UNTIL THE DELIVERY SYSTEM TIP IS AT THE TIP OF THE GUIDE SHEATH. REMOVE THE SYRINGE FROM THE GUIDE SHEATH. ENSURE THE VALVE IS CORRECTLY POSITIONED USING THE VALVE ALIGNMENT MARKERS. ENSURE GUIDE SHEATH IS LESS THAN 25% FLEXED. ADVANCE THE DELIVERY SYSTEM UNTIL HALF OF THE VALVE EXITS THE GUIDE SHEATH TIP. APPLY ADDITIONAL GUIDE SHEATH FLEX (UP TO 60%) AND/OR TORQUE TO ACHIEVE COAXIALITY WITH SAPIEN M3 DOCK. FULLY ADVANCE VALVE OUT OF GUIDE SHEATH INTO SAPIEN M3 DOCK. VERIFY THE CORRECT POSITION OF THE VALVE WITH RESPECT TO THE SAPIEN M3 DOCK. RETRACT THE FLEX CATHETER TIP AND GUIDE SHEATH TIP TO THE DOUBLE MARKERS. LOCK BALLOON LOCK. NO IFU/TRAINING DEFICIENCIES WERE IDENTIFIED. 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. 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. SINCE NO PRODUCT NON-CONFORMANCE OR IFU/TRAINING INADEQUACIES WAS IDENTIFIED, A PRA IS NOT REQUIRED. NO EDWARDS DEFECTS, WHICH COULD HAVE RESULTED IN THE COMPLAINT EVENT, WAS IDENTIFIED; THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION IS NOT REQUIRED. THE INFLATION DIFFICULTY WAS UNABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED AND NO APPLICABLE IMAGERY WAS PROVIDED. A REVIEW OF THE DHR DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. AS REPORTED, ''MID INFLATION OF THE VALVE THE ATRION DETACHED FROM THE COMMANDER M DEVICE. THE STOPCOCK CONNECTION THE COMMANDER M WAS MISALIGNED.'' ADDITIONALLY, IT WAS REPORTED ''THE TEAM DOES NOT FEEL THAT THERE WAS ANY MALFUNCTION OF ANY OF THE DEVICES, THEY FEEL IT WAS DUE TO MISALIGNMENT OF THE THREADS DURING PREPARATION.'' IN THIS CASE, THE INFLATION BALLOON WAS NOT ABLE TO COMPLETELY INFLATE LIKELY DUE TO THE OPERATOR INADEQUATELY THREADING THE 3-WAY STOPCOCK TO THE DELIVERY SYSTEM INFLATION PORT, RESULTING IN THE STOPCOCK WITH THE INFLATION DEVICE DETACHING FROM THE DELIVERY SYSTEM ONCE THE INFLATION DEVICE SYRINGE WAS COMPRESSED. AS SUCH, AVAILABLE INFORMATION SUGGESTS PROCEDURAL FACTORS (OPERATOR MISALIGNED THREADS OF STOPCOCK AND INFLATION PORT DURING DEVICE PREPARATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    RECORDS WERE RECEIVED WITH INFORMATION ABOUT THE PATIENT'S PRIOR MEDICAL HISTORY. ADDED INFORMATION TO B.7.

    Description of Event or Problem · 0

    AS REPORTED, DURING A COMPASSIONATE USE CASE, BY THE CLINICAL SPECIALIST IN THE FIELD, THIS CASE INVOLVED THE TREATMENT FOR A COMPASSIONATE USE PATIENT. THE ATRION SYRINGE DISCONNECTED FROM THE COMMANDER M DEVICE MID INFLATION OF THE VALVE THE ATRION DETACHED FROM THE COMMANDER M DEVICE. THE STOPCOCK CONNECTION THE COMMANDER M WAS MISALIGNED. THIS PROMPTED THE VALVE TO BE EXPANDED USING A SYRINGE WITH AN UNKNOWN AMOUNT OF VOLUME. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE FIELD CONFIRMED THAT THE DISCONNECTION OCCURRED WHERE THE STOPCOCK CONNECTS TO THE COMMANDER M INFLATION PORT. THE PERSON WHO PREPPED THE DEVICE MAY HAVE MISALIGNED THE THREADS AND WHEN THE ATRION DEVICE WAS USED TO DEPLOY THE VALVE THE STOPCOCK POPPED OFF THE DS. THE PHYSICIAN GRABBED A 50CC SYRINGE WITH CONTRAST AND CONNECTED IT DIRECTLY TO THE DS AND DEPLOYED THE VALVE. THE ATRION WITH STOPCOCK WAS THEN RECONNECTED (NOMINAL PLUS AN ADDITIONAL 4CC'S) AND USED TO POST-DILATE THE VALVE. THERE WAS NO INJURY TO THE PATIENT AND THE VALVE WAS SUCCESSFULLY DEPLOYED. THE TEAM DOES NOT FEEL THAT THERE WAS ANY MALFUNCTION OF ANY OF THE DEVICES, THEY FEEL IT WAS DUE TO MISALIGNMENT OF THE THREADS DURING PREPARATION. ADDITIONALLY, THE PATIENT WAS EXPERIENCING HYPOTENSION AFTER 1 TURN OUT THIS IS SOMETHING WE VERY RARELY SEE AND WAS A RESULT OF THE DOCK INTERACTING WITH THE ANATOMY IN SOME WAY. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092980 EDWARDS M COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9880CM29CL 64118606 00690103214321

    Patients

    Seq Age Sex Outcome Treatment
    1 Female