BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 17783314 · Received September 20, 2023

    Report

    Report Number
    2015691-2023-16060
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    September 15, 2023
    Report Date
    November 2, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : VALVE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6; TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION. THE 23MM SAPIEN 3 XT VALVE WAS NOT RETURNED FOR EVALUATION. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. IMAGERY WAS REVIEWED THAT CONFIRMED MODERATE TO SEVERE CENTRAL REGURGITATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS RELATING TO THE COMPLAINT CODE. THE FOLLOWING INSTRUCTIONS FOR USE (IFU) WERE REVIEWED: NOVAFLEX AND DELIVERY SYSTEM WITH SAPIEN XT. BASED ON THIS REVIEW, NO IFU/TRAINING 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. THE REPORTED EVENT OF CENTRAL LEAK 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 WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. AS REPORTED, "APPROXIMATELY 7 YEARS AND 6 MONTHS AFTER TAVR, HEART FAILURE WAS NOTED. ON THE SAME DAY, CT WAS PERFORMED, AND SEVERE CENTRAL LEAK WAS DIAGNOSED. BECAUSE THE CENTRAL LEAK WAS SIGNIFICANT, IT WAS CONSIDERED TO BE ASSOCIATED TO THE VALVE LEAFLETS (IT MIGHT HAVE BEEN VALVE LEAFLETS TORN). HOWEVER, THE EXACT CAUSE WAS UNKNOWN, AND IT WAS ALSO UNKNOWN IF THERE WERE THE VALVE LEAFLETS TOR. THE PATIENT'S COMORBIDITIES WERE UNKNOWN." PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. IN THIS CASE, DUE TO INSUFFICIENT INFORMATION, 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    UPDATE TO B3 AND B5.

    Description of Event or Problem · 0

    APPROXIMATELY 6 YEARS AND 11 MONTHS POST-TAVR PROCEDURE USING A 23MM SAPIEN 3 XT VALVE VIA TRANSAPICAL APPROACH, EXAMINATION REVEALED A MILD CENTRAL LEAK. THE PATIENT WAS PLACED ON FOLLOW-UP OBSERVATION. APPROXIMATELY 7 YEARS AND 6 MONTHS AFTER TAVR, THE PATIENT PRESENTED WITH HEART FAILURE AND SEVERE CENTRAL LEAK FOR WHICH THE PATIENT WAS HOSPITALIZED. THE PLAN IS FOR THE PATIENT TO UNDERGO A VALVE IN VALVE PROCEDURE IN THE NEAR FUTURE. THE PATIENT HAD NO REMARKABLE MEDICAL HISTORY.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A VALVE IN VALVE PROCEDURE USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE WITH NO ADVERSE EVENTS OR MALFUNCTIONS. PARAVALVULAR LEAK (PVL) WAS OBSERVED FROM THE 9 O'CLOCK DIRECTION, BUT IT WAS CONSIDERED THAT THE LEAK WAS FROM THE COMMISSURE PART AND WOULD NOT ESCALATE FURTHER. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76250 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23J

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Required Intervention| H