BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMANDER M DELIVERY SYSTEM

    MDR report key: 19234508 · Received May 2, 2024

    Report

    Report Number
    2015691-2024-03301
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 11, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103217537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE, COMMANDER M DELIVERY SYSTEM - MODEL 9880CM29CLPD, IS NOT SOLD OR MARKETED IN THE US; HOWEVER, IT IS DEEMED SIMILAR TO THE COMMANDER DELIVERY SYSTEM - MODEL 9600LDS29, PMA # P140031. THE PMA/510K FIELD WILL BE BLANK. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION AND INCLUDES ADDITIONAL INFORMATION BASED ON INVESTIGATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN CORRECTED/UPDATED: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) AND H10 (PROVIDE NARRATIVE/DATA). THE DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION AS IT WAS DISCARDED. DUE TO THE UNAVAILABILITY OF THE DEVICE, NO VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS COULD BE PERFORMED. IMAGERY WAS PROVIDED FOR EVALUATION. A REVIEW OF THE PROVIDED IMAGERY REVEALED THE PIGTAIL WIRE HAD PROLAPSED BACK INTO THE LEFT ATRIUM. IT WAS ABLE TO BE REPOSITIONED BACK INTO THE CORRECT LOCATION. IN ADDITION, IT WAS NOTED THAT THERE WAS 100% CONTRAST THAT WAS CAUSING PREPPING DIFFICULTY. IT ALSO LED TO HIGH RESISTANCE FORCES BEING EXPERIENCED DURING INFLATION OF THE VALVE AS THE BALLOON WAS OBSERVED DURING THE INFLATION TO BE VISIBLY DARKER. IT APPEARS THERE WAS ALSO RESISTANCE WHEN INFLATING THE BALLOON. AFTERWARDS, THE VALVE BEGAN TO EXPAND. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND IT DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENTS. THE INSTRUCTIONS FOR USE (IFU)/TRAINING MANUALS WERE REVIEWED FOR GUIDANCE/INSTRUCTION INVOLVING THE USAGE OF THE M3 SYSTEM. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO 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. IN THIS CASE, THE RESISTANCE EXPERIENCED WITH THE GUIDEWIRE DURING ADVANCEMENT OF THE DELIVERY SYSTEM WITH VALVE THROUGH THE SHEATH, DEVICE PREPPING DIFFICULTY, AND INFLATION DIFFICULTY WERE ABLE TO BE CONFIRMED FROM REVIEW OF THE IMAGERY. THE REPORTED EVENTS DO NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. A REVIEW OF THE IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. AS REPORTED, "THE COMMANDER M DELIVERY SYSTEM WITH SAPIEN M3 VALVE WERE ADVANCED THROUGH THE GUIDE SHEATH (GS). WITH 50% OF THE VALVE OUT OF THE GS TIP, WHILE ATTEMPTING TO EXIT THE GS WITH THE VALVE, THE WIRE HAD MIGRATED UP THROUGH THE DOCK'S ENCIRCLING TURNS AND INTO THE LA. USING THE COMMANDER M DELIVERY SYSTEM NOSECONE, THE WIRE WAS RE-ADVANCED BACK THROUGH THE DOCK". ADDITIONALLY, AS REPORTED, "UPON INITIAL DEPLOYMENT, IT LOOKED AS THOUGH THE ATRION DEVICE WAS PREPPED WITH 100% CONTRAST IN THE BALLOON". PER THE PROCEDURAL MANUAL, DURING THE PREPARATION OF THE DEVICE, THE INSTRUCTIONS ARE TO USE A DILUTED CONTRAST (15 ML CONTRAST:85 ML HEPARINIZED SALINE), BUT THE CONTRAST WAS NOT PREPPED AS INSTRUCTED. THIS WAS NOTICED DURING THE PROCEDURE WHEN A FLUOROSCOPY PERFORMED HAD REVEALED THE BALLOON DURING INFLATION WAS VISIBLY DARKER WHICH IS AN INDICATION THAT THE DILUTED CONTRAST SOLUTION WAS NOT PREPPED AS INSTRUCTED IN THE PROCEDURAL MANUAL. IN ADDITION, "THE OPERATOR INDICATED THERE WAS A LOT OF RESISTANCE AND DIFFICULTY BOTTOMING OUT THE ATRION DEVICE DURING INFLATION". THIS LED TO DIFFICULTY IN INFLATING THE BALLOON DURING THE PROCEDURE. BASED ON THE IMAGERY PROVIDED, IT APPEARS THAT AN INCORRECT RATIO OF CONTRAST WAS USED THROUGHOUT THE PROCEDURE. USING 100% CONTRAST IN THE PROCEDURE CAUSES HIGHER INFLATION FORCES SINCE 100% CONTRAST SOLUTION IS MORE VISCOUS THAN THE DILUTED CONTRAST SOLUTION. IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (INADEQUATE WIRE MANAGEMENT) AND NOT USING THE CORRECT RATIO OF CONTRAST SOLUTION MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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. 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 FROM A CLINICAL STUDY, DURING THE TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 29 MM SAPIEN M3 VALVE, THE COMMANDER M DELIVERY SYSTEM WITH SAPIEN M3 VALVE WERE ADVANCED THROUGH THE GUIDE SHEATH (GS). WITH 50% OF THE VALVE OUT OF THE GS TIP, WHILE ATTEMPTING TO EXIT THE GS WITH THE VALVE, THE WIRE HAD MIGRATED UP THROUGH THE DOCK'S ENCIRCLING TURNS AND INTO THE LEFT ATRIUM (LA). USING THE COMMANDER M DELIVERY SYSTEM NOSECONE, THE WIRE WAS RE-ADVANCED BACK THROUGH THE DOCK. THE OPERATOR WAS NOTIFIED THAT THIS WOULD BE A LONG PACER RUN FOR VALVE DEPLOYMENT. WITH THE DISTAL PORTION OF THE VALVE POSITIONED APPROXIMATELY 3 MM FROM THE MOST VENTRICULAR FUNCTIONAL TURN, THE VALVE WAS DEPLOYED. UPON INITIAL DEPLOYMENT, IT APPEARED AS THOUGH THE ATRION DEVICE WAS PREPPED WITH 100% CONTRAST IN THE BALLOON. THE OPERATOR INDICATED THERE WAS A LOT OF RESISTANCE AND DIFFICULTY BOTTOMING OUT THE ATRION DEVICE DURING INFLATION. ADDITIONAL INFORMATION WAS RECEIVED REVEALING THERE WAS SOME DIFFICULTY PREPPING THE SYRINGE AND DELIVERY SYSTEM PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842043 COMMANDER M DELIVERY SYSTEM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9880CM29CLPD 65389248 00690103217537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown