BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 22484569 · Received July 11, 2025

    Report

    Report Number
    2015691-2025-05641
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 19, 2025
    Report Date
    August 18, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103207828
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS NUMBER THREE OF THREE MANUFACTURERS BEING SUBMITTED FOR THIS CASE. SEE 2015691-2025-04888. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR COMPLETION TO THE ENGINEERING EVALUATION. THE FOLLOWING SECTIONS OF THIS REPORT HAS BEEN UPDATED: UPDATE TO B4, G3, G6, H2, H6, H11. INVESTIGATION FINDINGS: SEPARATION PROBLEM. THE PRODUCT WAS NOT RETURNED; THEREFORE, A NO PRODUCT RETURN INVESTIGATION WAS COMPLETED. AS A DEVICE WAS NOT RETURNED, VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL TESTING WERE UNABLE TO BE DONE. THE PROVIDED IMAGERY WAS REVIEWED, AND THE FOLLOWING WAS OBSERVED: 3MENSIO REPORT: CALCIFICATION IN THE ANNULUS. PROCEDURAL IMAGERY: THE S3U VALVE WAS LOCATED PROXIMALLY TO THE PRE-EXISTING S3 VALVE AND POSITIONED BEYOND THE DISTAL VALVE ALIGNMENT MARKERS IN THE ASCENDING AORTA, SUGGESTING CROSSING DIFFICULTIES AND DEVICE MANIPULATION TO FREE THE STUCK SYSTEM. THE DISTAL PORTION OF THE DELIVERY SYSTEM, INCLUDING THE BALLOON, BECAME SEPARATED, WITH THE S3U VALVE REMAINING ON THE DISTAL END OF THE INFLATION BALLOON AND POSITIONED IN THE DESCENDING AORTA. THE GUIDEWIRE LUMEN ALSO APPEARED TO BE BROKEN AND SEPARATED. THE S3U VALVE AND THE DISTAL PORTION OF THE DS WERE SECURED WITH AN ENDOGRAFT IN THE DESCENDING AORTA. POST-PROCEDURAL DEVICE IMAGE: THE OUTER LAYER OF THE GUIDEWIRE LUMEN DISTAL TO THE CRIMP INDICATOR MARKER INDICATOR WAS STRIPPED AWAY AND LEFT INSIDE THE PATIENT. THE TRIPLE MARKERS AND VALVE ALIGNMENT MARKERS SHOWN IN ONE PHOTO WERE THE SEPARATE LAYERS. AS NO DEVICE WAS RETURNED AND THERE IS NO EVIDENCE TO SUPPORT A MANUFACTURING/DESIGN DEFECT POTENTIALLY CONTRIBUTED TO THE COMPLAINT, A MANUFACTURING MITIGATION REVIEW IS NOT REQUIRED. THE COMMANDER DELIVERY SYSTEM IFU WAS REVIEWED. POTENTIAL ADVERSE EVENTS INCLUDE, 'DEVICE EMBOLIZATION'. NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION.' THE COMPLAINTS FOR DIFFICULTY OR INABILITY TO CROSS NATIVE ANNULUS AND/OR BIOPROSTHESIS, BALLOON LEAK, DIFFICULTY OR INABILITY TO WITHDRAW SYSTEM THROUGH VASCULATURE, AND SYSTEM COMPONENTS SEPARATE DURING USE - DISTAL TIP ARE CONFIRMED BASED ON REVIEW OF PROVIDED IMAGERY. AS THE DEVICE WAS NOT RETURNED, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL EXAMINATION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THEREFORE, THE PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. HOWEVER, A REVIEW OF THE DHR DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. FURTHERMORE, NO ABNORMALITIES WERE REPORTED DURING DEVICE UNPACKING OR PREPARATION. AS REPORTED, '[PRE-EXISTING] SAPIEN 3 VALVE [WAS] FAILING DUE TO STENOSIS AND REGURGITATION (DEGENERATION). ['] DURING THE VALVE IN VALVE PROCEDURE, THE PATIENT INITIALLY NEEDED LEAFLET MODIFICATION TO THE RIGHT CORONARY CUSP (RCC). THE PHYSICIAN PERFORMED A UNICORN PROCEDURE. WHEN GOING IN WITH THE [S3U] VALVE, THE VALVE GOT STUCK GOING THROUGH THE LEAFLET. THE NOSE CONE APPEARED TO BE THROUGH THE LEAFLET, BUT THE VALVE WOULD NOT ADVANCE. THE PHYSICIAN TRIED TO PULL THE VALVE BACK AND THE VALVE APPEARED TO BE STUCK. THEY ATTEMPTED MULTIPLE MANEUVERS TO DISLODGE THE NOSE CONE AND COMMANDER FROM THE 23S3U AND WERE UNSUCCESSFUL. THE BALLOON WAS NOTICED TO BE COMPROMISED (LEAKING) WHEN PULLING BACK ON THE ATRION AND BLOOD WAS NOTED IN THE SYRINGE.['] THE PHYSICIAN PULLED BACK ON THE COMMANDER ['] AND THE COMMANDER SHAFT SEPARATED FROM THE BALLOON.' IT WAS REPORTED THAT THE PERCEIVED ROOT CAUSE OF THE CROSSING DIFFICULTY WAS 'THAT THE LEAFLET WAS NOT FULLY DILATED.' PER THE TRAINING MANUAL, INADEQUATE BAV CAN CONTRIBUTE TO CROSSING DIFFICULTY. INADEQUATE BALLOON EXPANSION MAY RESULT IN INCOMPLETE LEAFLET SEPARATION. THIS CAN CREATE RESISTANCE DURING CATHETER ADVANCEMENT. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (INADEQUATE PREDILATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THIS CASE, IT WAS REPORTED THAT THE VALVE GOT STUCK WHEN CROSSING THE LEAFLET. THIS INTERACTION BETWEEN THE CRIMPED VALVE AND THE PRE-EXISTING THV LIKELY CONTRIBUTED TO THE DIFFICULTY WITHDRAWING THE SYSTEM. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (DEVICE INTERACTION WITH PRE-EXISTING IMPLANT) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PER REVIEW OF PROVIDED PROCEDURAL DEVICE IMAGERY, THE DISTAL PORTION OF THE DELIVERY SYSTEM, INCLUDING THE BALLOON WERE SEPARATED. THIS INDICATED THAT THE INFLATION PATHWAY HAS BEEN COMPROMISED. IN THIS CASE, DIFFICULTY WAS REPORTED WHEN ATTEMPTING TO PULL THE VALVE BACK AND MULTIPLE MANEUVERS WERE ATTEMPTED WITHOUT SUCCESS. THE HIGH WITHDRAWAL FORCE AND DEVICE MANIPULATION APPLIED TO OVERCOME THE RESISTANCE LIKELY CONTRIBUTED TO THE REPORTED DAMAGE AND CONSEQUENT LEAKAGE. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (HIGH WITHDRAWAL FORCE, DEVICE MANIPULATION) MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON LEAK AND DISTAL TIP SEPARATION. PER THE ASSESSMENT, IT HAS BEEN DETERMINED THAT NO CAPA, SCAR, OR PRA IS REQUIRED AS THE ESTABLISHED TRIGGERS HAVE NOT BEEN MET. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 7 YEARS POST-IMPLANT OF A 23 MM SAPIEN 3 (S3) VALVE IN THE AORTIC POSITION, THE VALVE WAS NOTED TO BE FAILING DUE TO STENOSIS AND REGURGITATION (DEGENERATION). THE PATIENT UNDERWENT A VALVE IN VALVE USING A 23MM SAPIEN 3 ULTRA (S3U) WHICH WAS NOTED TO HAVE MULTIPLE PROCEDURAL COMPLICATIONS, LEADING ONE THV AND DELIVERY SYSTEM BALLOON TO BE SECURED WITH AN ENDOGRAFT IN THE DESCENDING AORTA. POST PROCEDURE THE PATIENT WAS SENT TO ICU IN STABLE CONDITION. DURING THE VALVE IN VALVE PROCEDURE, THE PATIENT INITIALLY REQUIRED LEAFLET MODIFICATION TO THE RIGHT CORONARY CUSP (RCC) OF THE 232MM S3 VALVE TO PREVENT A POSSIBLE CORONARY OCCLUSION. THE PHYSICIAN PERFORMED A UNICORN PROCEDURE BY CREATING A CHANNEL THROUGH THE RCC (LEAFLET) OF THE S3 VALVE. WHEN ADVANCING THE S3U VALVE THROUGH THE UNICORN CREATED PATHWAY, THE S3U VALVE GOT STUCK GOING THROUGH THE S3 LEAFLET. THE NOSE CONE APPEARED TO BE THROUGH THE LEAFLET, BUT THE VALVE WOULD NOT ADVANCE. THE TEAM TRIED TO PULL THE S3U VALVE BACK, HOWEVER THE VALVE APPEARED TO BE STUCK. MULTIPLE ATTEMPTS AND MANEUVERS TO DISLODGE THE COMMANDER FROM THE S3 VALVE WERE UNSUCCESSFUL. THE BALLOON WAS NOTED TO BE COMPROMISED WHEN PULLING BACK ON THE ATRIUM AND BLOOD WAS FOUND IN THE SYRINGE. IT WAS DECIDED TO RE-PUNCTURE THE S3 VALVE RCC FROM THE CONTRA-LATERAL SIDE AND RE-BALLOON IN ATTEMPT TO BREAK THE S3U VALVE AND COMMANDER DS FREE TO BRING THE ENTIRE SYSTEM DOWN TO THE ESHEATH+. WHEN BALLOONING THE RCC THE PATIENT DEVELOPED WIDE OPEN AORTIC INSUFFICIENCY AND CPR WAS INITIATED. WITH THE S3U VALVE AND DS STILL STUCK ACROSS THE S3 RCC, THE PHYSICIAN PULLED BACK ON THE DS WHILE CPR WAS INITIATED, AND THE COMMANDER NOSE TIP WITH THE S3U VALVE SEPARATED FROM THE DS. THE S3U VALVE AND DS NOSE-TIP REMAINED STUCK IN THE SAPIEN 3 LEAFLET. IT WAS DECIDED TO PREPARE A NEW VALVE AND SYSTEM AND DEPLOY THE VALVE. WHEN DEPLOYING THE SECOND S3U VALVE, THE FIRST S3U VALVE BROKE FREE AND EMBOLIZED INTO THE ASCENDING AORTA. THE S3U VALVE WAS BROUGHT DOWN INTO THE DESCENDING AORTA AND AN ENDO-GRAFT WAS DEPLOYED TO COVER THE VALVE AND BALLOON. THE PATIENT WAS SENT TO ICU IN STABLE CONDITION. PER FOLLOW-UP COMMUNICATION, THE PATIENT PASSED AWAY 10 DAYS POST-PROCEDURE, HOWEVER THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996805 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23A 66319668 00690103207828

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention