BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS INFLATION DEVICE

    MDR report key: 15237189 · Received August 16, 2022

    Report

    Report Number
    2015691-2022-07349
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 25, 2022
    Report Date
    September 20, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MAV
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDWARDS INFLATION DEVICE COMMERCIALIZED IN EUROPE BY EDWARDS LIFESCIENCES IS SIMILAR TO THE MARKETED DEVICE IN THE UNITED STATES BY ATRION MEDICAL PRODUCTS, INC. UNDER 510K (K032840). INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    UPDATED H6- TYPE OF INVESTIGATION, INVESTIGATION FINDINGS. CORRECTED H6- COMPONENT CODE, INVESTIGATION CONCLUSIONS . THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE COMPLAINT FOR INFLATION DIFFICULTY WAS UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF RETURNED DEVICE/PROCEDURAL IMAGERY. A REVIEW OF DHR DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING NON-CONFORMANCE POTENTIALLY CONTRIBUTING TO THE REPORTED EVENT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. 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. AS REPORTED, "DURING VALVE DEPLOYMENT, THE IMPLANTING DOCTOR WAS UNABLE TO COMPLETELY EMPTY THE SYRINGE AT THE END OF INFLATION AND 2ML REMAINED IN THE SYRINGE." PER ADDITIONALLY PROVIDED INFORMATION, "THERE MAY HAVE BEEN AN ERROR WITH THE AMOUNT OF FLUID IN ATRION, HOWEVER, UNABLE TO BE CONFIRMED. IT IS ALSO UNSURE IF THE ATRION WAS FULLY UNLOCKED BEFORE DEPLOYMENT, OR IT MAY HAVE BEEN ACCIDENTLY LOCKED DURING DEPLOYMENT. ON THE BACK TABLE, THE CS RE-INFLATED THE ATRION, AND WAS ONLY ABLE TO DEPLOY UNTIL THE 1ML MARK." PER TRAINING MANUALS, "USE NOMINAL VOLUME. THE DELIVERY SYSTEM REQUIRES A PRESCRIBED VOLUME FOR THV DEPLOYMENT AND PROPER FUNCTION." USING EXCESS VOLUME COULD HAVE POTENTIALLY CAUSED DIFFICULTY WITH BEING ABLE TO EXPEL REMAINING LIQUID FROM THE INFLATION DEVICE AS THIS WOULD REQUIRE OVERCOMING THE BACK PRESSURE ASSOCIATED WITH THE FULLY INFLATED BALLOON. ADDITIONALLY, THIS REPORTED EVENT MAY HAVE ALSO BEEN A PERCEPTION ISSUE WHEN EXAMINING THE DEPLOYMENT OF THE THV. POTENTIAL PERCEPTION OF DEPLOYED THV MAY HAVE MISLED THE USER TO ASSUME THAT THE VALVE WAS FULLY DEPLOYED, AND ANY FURTHER INFLATION OF THE BALLOON COULD LEAD TO A BURST. THIS MIGHT HAVE PROMPTED THE USER TO NOT FULLY USE ALL OF THE NOMINAL VOLUME IN THE INFLATION DEVICE. FURTHERMORE, AS LISTED IN THE TRAINING MANUAL, "NEVER LOCK THE INFLATION DEVICE DURING BAV OR THV DEPLOYMENT." IF THE INFLATION DEVICE WAS LOCKED OR PARTIALLY LOCKED BY THE USER DURING THV DEPLOYMENT, IT COULD HAVE PREVENTED THE PLUNGER FROM ADVANCING FORWARD INTO NEUTRAL POSITION AND EXPELLING THE ENTIRE AMOUNT OF LIQUID INTO THE BALLOON. IT IS ALSO POSSIBLE THAT THE PLUNGER WAS NOT MANIPULATED PROPERLY ONCE IN NEUTRAL POSITION, WHICH IS DONE BY LOCKING AND TURNING IT CLOCKWISE TO REACH THE SPECIFIED INFLATION PRESSURE. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (USE ERROR) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED FROM OUR AFFILIATES IN AUSTRALIA, THIS WAS A CASE OF A 23MM SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN AORTIC POSITION BY TRANSFEMORAL APPROACH. DE-AIRING WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE FOR BOTH THE ATRION AND COMMANDER DELIVERY SYSTEM. DURING VALVE DEPLOYMENT, THE IMPLANTING DOCTOR WAS UNABLE TO COMPLETELY EMPTY THE SYRINGE AT THE END OF INFLATION AND 2ML REMAINED IN THE SYRINGE. DESPITE THIS, THE VALVE WAS FULLY INFLATED WITH A FANTASTIC RESULT. NO POST DILATION WAS NEEDED. THERE WAS NO PARAVALVULAR LEAK. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DOING WELL POST PROCEDURE. AS REPORTED, THERE WAS NO LEAKAGE IN THE SYSTEM, AND IT IS UNKNOWN IF THE EVENT IS RELATED TO THE COMMANDER DELIVERY SYSTEM OR ATRION SYRINGE; HOWEVER, ACCORDING TO THE PHYSICIANS, IT SEEMED TO BE MORE LIKELY A POSSIBLE ISSUE WITH THE SYRINGE. THERE MAY HAVE BEEN AN ERROR WITH THE AMOUNT OF FLUID IN ATRION BUT THIS WAS UNABLE TO BE CONFIRMED. IT WAS ALSO NOT CONFIRMED IF THE ATRION WAS FULLY UNLOCKED BEFORE DEPLOYMENT, OR IF IT MAY HAVE BEEN ACCIDENTALLY LOCKED DURING DEPLOYMENT. ON THE BACK TABLE, THE EDWARDS CLINICAL SPECIALIST RE-INFLATED THE ATRION, AND WAS ONLY ABLE TO DEPLOY UNTIL THE 1ML MARK. THE EDWARDS CLINICAL SPECIALIST COMMENTED THAT THIS IS MOST LIKELY A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917031 EDWARDS INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV EDWARDS LIFESCIENCES 96402 96402340

    Patients

    Seq Age Sex Outcome Treatment
    1 Female