BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 23008284 · Received September 9, 2025

    Report

    Report Number
    2015691-2025-07414
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    June 1, 2017
    Report Date
    November 12, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE FOR JOURNAL ARTICLE: KHAN JM, BABALIAROS VC, GREENBAUM AB, MCCABE JM, ROGERS T, ENG MH, FOERST JR, YAZDANI S, PAONE G, GLEASON PT, HALABY RN, BRUCE CG, TIAN X, STINE AM, LEDERMAN RJ. 5-YEAR OUTCOMES OF ANTERIOR MITRAL LEAFLET LACERATION TO PREVENT OUTFLOW OBSTRUCTION. JACC CARDIOVASC INTERV. 2024 SEP 23;17(18):2157-2167. THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE/PRE-STENT AND THE LANDING ZONE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST-DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE LANDING ZONE, UNEVEN DISTRIBUTION OF CALCIUM ON THE LANDING ZONE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE, AND VALVE UNDER-SIZING. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVES. THE DEVICE TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROPER IMAGING SCREENING REQUIREMENTS, INCLUDING THE USE OF GOOD QUALITY ECHOCARDIOGRAPHY AND/OR COMPUTED TOMOGRAPHY (CT) TO APPROPRIATELY MEASURE THE LANDING ZONE, ASSESS THE CONTENT AND DISTRIBUTION OF CALCIUM, AND OTHER PATIENT ANATOMICAL FACTORS. MULTIPLE IMAGING MODALITIES SHOULD BE CONSIDERED DURING VALVE SIZE SELECTION. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER TRANSCATHETER HEART VALVE ARE ALSO DISCUSSED. THE DEVICE TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING PATIENTS SCREENING AND PROCEDURAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES ARE ALSO INCLUDED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME; HOWEVER, THE EVENT COULD BE RELATED TO THE MECHANISMS DESCRIBED ABOVE. 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 THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION TO DOCUMENT THE RELATED MANUFACTURER REPORT NUMBERS IN SECTION H10 (RELATED REPORT NUMBERS).

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INCLUDE ADDITIONAL INFORMATION. THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE SEE MANUFACTURER REPORT NUMBERS 2015691-2025-07407, 2015691-2025-07409, 2015691-2025-07411, 2015691-2025-07430, AND 2015691-2025-07432 FOR DETAILS OF THE OTHER EVENTS.

    Description of Event or Problem · 0

    AS REPORTED FROM THE JOURNAL ARTICLE "5-YEAR OUTCOMES OF ANTERIOR MITRAL LEAFLET LACERATION TO PREVENT OUTFLOW OBSTRUCTION", A TOTAL OF THIRTY SUBJECTS WERE ENROLLED IN A LAMPOON TRIAL BETWEEN JUNE 2017 AND JUNE 2018. SUBJECTS UNDERWENT EITHER A LAMPOON AND VALVE-IN-MITRAL ANNULAR CALCIFICATION (MAC) PROCEDURE OR A LAMPOON AND VALVE-IN-RING PROCEDURE USING A SAPIEN 3 VALVE. THE FOLLOWING EVENT WAS IDENTIFIED: ONE CASE OF PARAVALVULAR LEAK (PVL) THAT REQUIRED A TRANSCATHETER PLUG CLOSURE. NO FURTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836314 SAPIEN 3 TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention