BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 22484561 · Received July 11, 2025

    Report

    Report Number
    2015691-2025-05640
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103201321
    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 TWO OF THREE MANUFACTURERS BEING SUBMITTED FOR THIS CASE. 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. 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 NOTED: CRIMPED THV VISIBLE DURING CROSSING ATTEMPT, NO MOTION OBSERVED AND THV ALIGNED TOO DISTAL OVER ALIGNMENT MARKERS. SEPARATED DISTAL BALLOON ASSEMBLY WITH CRIMPED THV ANCHORED AGAINST WALL OF VASCULATURE BY GRAFT. THE INCIDENT THV REMAINED CRIMPED, AND LOCATED AT DESCENDING AORTA. THE SECOND THV WAS IMPLANTED WITHIN THE PRE-EXISTING THV. ADDITIONALLY, 3MENSIO IMAGERY WAS PROVIDED HOWEVER IT WAS PRE-TAVR (VIV) AND NOT RELEVANT TO THIS COMPLAINT EVENT; THEREFORE NO FINDINGS ARE NOTED. 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 WITH S3/ S3U/ S3UR IFU WAS REVIEWED. POTENTIAL ADVERSE EVENTS INCLUDE: DEVICE EMBOLIZATION AND DEVICE MIGRATION OR MALPOSITION REQUIRING INTERVENTION. NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION.' THE COMPLAINT FOR INTERVENTIONAL DEVICE INTERACTS WITH PRE-EXISTING IMPLANTABLE DEVICE WAS CONFIRMED BASED ON THE PROVIDED IMAGERY. A REVIEW OF THE DHR AND LOT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. AS REPORTED, 'THE PATIENT UNDERWENT A VALVE IN VALVE 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... THE PHYSICIAN PERFORMED A UNICORN PROCEDURE. WHEN GOING IN WITH THE VALVE (SN (B)(6), THE VALVE GOT STUCK GOING THROUGH THE LEAFLET. THE NOSE CONE APPEARED TO BE THROUGH THE LEAFLET, BUT THE VALVE WOULD NOT ADVANCE.' IN THIS CASE, THE UNICORN LEAFLET MODIFICATION TECHNIQUE (CREATING A HOLE IN THE PRE-EXISTING THV LEAFLET AND ADVANCE THE DELIVERY SYSTEM WITH NEW THV THROUGH THE LEAFLET AND DEPLOY) WAS PERFORMED FOR THE PRE-EXISTING THV PRIOR TO INCIDENT VALVE IMPLANTATION. THE EXACT REASON FOR THE VALVE STUCK WITH PRE-EXISTING THV LEAFLET WAS UNKNOWN BASED ON AVAILABLE INFORMATION, BUT IT WAS LIKELY RELATED TO THE UNICORN LEAFLET MODIFICATION TECHNIQUE. AS SUCH AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (UNICORN LEAFLET MODIFICATION TECHNIQUE) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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
    995916 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX23A 00690103201321

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention