BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 17495755 · Received August 10, 2023

    Report

    Report Number
    2015691-2023-15144
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 15, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS WERE UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF RELEVANT IMAGERY AND MEDICAL RECORDS. 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 IFU TRAINING MATERIALS REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. IT SHOULD BE NOTED THAT A SAPIEN 3 THV WAS DEPLOYED IN A PRE EXISTING BIOPROSTHETIC AORTIC VALVE IN THIS CASE. IN CHINA, EDWARDS SAPIEN 3 VALVE WITH COMMANDER DELIVERY SYSTEM IS INDICATED FOR NATIVE AORTIC VALVE REPLACEMENT ONLY. THEREFORE, THIS WAS OFF LABEL OPERATION. PER TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, THE CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. POTENTIAL ROOT CAUSES FOR CENTRAL REGURGITATION AT TIME OF IMPLANT INCLUDES VALVE MALPOSITION, SLOW RECOVERY OF BLOOD FLOW, LEAFLET IMPINGEMENT DUE TO CALCIFICATION (FOR NATIVE LANDING ZONE), LEAFLET IMPINGEMENT DUE TO GUIDEWIRE, OVERINFLATION POST DILATION, AND UNDER EXPANSION. TYPICALLY, MILD REGURGITATION IS NOT UNUSUAL AFTER INITIAL VALVE REPLACEMENT, AND IS USUALLY TOLERATED BY PATIENTS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING REOPERATION IN THE IMMEDIATE POST OPERATIVE PERIOD IS DUE TO PATIENT AND PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. IN ADDITION, THE TECHNICAL SUMMARY OUTLINES THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, AND FLOWCO TESTING FOR EACH VALVE). THESE INSPECTIONS AND TESTING FURTHER SUPPORT THAT IT IS UNLIKELY THAT A DEFECT PRESENT IN MANUFACTURING CONTRIBUTED TO THE COMPLAINT. THE TECHNICAL SUMMARY ALSO OUTLINES THE INSTRUCTIONS FOR VALVE PREPARATION HANDLING, AND DEPLOYMENT. THE CENTRAL REGURGITATION WAS NOTED AFTER THE POST DILATION OF THE THV WITH NON EW DEVICE. PER TRAINING MANUAL, IT IS RECOMMENDING TO POST DILATE WITH SAME BALLOON. IN THIS CASE, DEPLOYING THE VALVE USING MORE THAN THE PRESCRIBED VOLUME OR ATTEMPTING A SECOND INFLATION MAY RESULT IN INABILITY FOR THE VALVE LEAFLETS TO PROPERLY FUNCTION. THE INCREASE IN VALVE DIAMETER DUE TO OVERINFLATION OR POST DILATION MAY PREVENT PROPER MOTION OF THE THV LEAFLETS RESULTING IN THV REGURGITATION. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (POST DILATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. AS REPORTED, IN ECHO IT WAS FOUND THERE WAS SEVERE CENTRAL REGURGITATION, WHICH MAY BE INDICATIVE OF SAPIEN 3 VALVE LEAFLETS TEARING AFTER POST DILATION WITH A 20MM ATLAS BAV AT 18 ATMOSPHERIC PRESSURE. IT IS POSSIBLE THAT THE VALVE WAS OVER EXPANDED OR STRETCHED DURING THE POST DILATION WITH NON EW DEVICE, RESULTING IN LEAFLET TEAR. HOWEVER, THE SITE STATED THAT CENTRAL REGURGITATION MAY DUE TO LEAFLET TEAR, SO LEAFLET TEAR WAS NOT FULLY SURE FOR THIS CASE. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (POST DILATION) MAY HAVE CONTRIBUTED TO REPORTED EVENT.. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN CHINA, REGARDING AN IMPLANT CASE OF A 20MM SAPIEN 3 VALVE WITHIN A 21MM MOSAIC SURGICAL VALVE IN AORTIC POSITION. DURING PROCEDURE, DIFFICULTIES WERE FOUND TO CROSS THE SURGICAL VALVE (IT TOOK ABOUT 40 MINUTES). THE SURGICAL VALVE WAS ABLE TO BE CROSSED WITH THE HELP OF A FLEXIBLE TRANSVALVULAR CATHETER. THE 20MM SAPIEN 3 VALVE WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE PRESSURE DIFFERENCE ACROSS THE VALVE PRIOR SAPIEN 3 VALVE IMPLANT WAS 60MMHG AND, AFTER IMPLANT WAS 43MMHG. THEREFORE, IT WAS DECIDED TO POST-DILATE THE SAPIEN 3 VALVE WITH A 20MM ATLAS BAV; AT 18 ATMOSPHERIC PRESSURE, BLOOD PRESSURE DECREASED. EPINEPHRINE WAS ADMINISTRATED TO THE PATIENT AND, AT THE SAME TIME IN ECHO IT WAS FOUND THERE WAS SEVERE CENTRAL REGURGITATION, WHICH MAY BE INDICATIVE OF SAPIEN 3 VALVE LEAFLETS TEARING. A SECOND 20MM SAPIEN 3 VALVE WAS SMOOTHLY IMPLANTED AND PATIENT'S BLOOD PRESSURE SLOWLY RECOVERED. THE PATIENT DID NOT SUFFER ANY INJURY FROM THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100152 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX20

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention