BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 24573141 · Received March 11, 2026

    Report

    Report Number
    2015691-2026-13129
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    May 1, 2016
    Report Date
    April 1, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED TO UPDATE THE FOLLOWING SECTION: H10 RELATED REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM MAY 2016 AND OCTOBER 2022. THEREFORE, (B)(6) 2016, WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THE SAPIEN XT AND SAPIEN 3 WERE IDENTIFIED IN THE LITERATURE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBER ASSOCIATED WITH AN EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE IS P130009. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE P140031 AND P200015. 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 (ALL MODELS). 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. THE CAUSE OF THE PVL CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. LITERATURE REFERENCE: BELAHNECH, Y., MARTI-AGUASCA, G., DOS-SUBIRA, L., BETRIAN-BLASCO, P., GARCIA DEL BLANCO, B., CALVO-BARCELO, M., ... & FERREIRA-GONZALEZ, I. (2025). MID-TERM OUTCOMES OF PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH EDWARDS-SAPIEN BIOPROSTHESIS IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT. SCIENTIFIC REPORTS, 15(1), 3977.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE "MID-TERM OUTCOMES OF PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH EDWARDS-SAPIEN BIOPROSTHESIS IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT", BY CORRESPONDING AUTHOR DR. YASSIN BELAHNECH, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE PATIENT WITH A 20, 23, 26, OR 29 MM SAPIEN XT OR SAPIEN 3 VALVE IMPLANTED IN THE PULMONIC POSITION (NON-NATIVE RIGHT VENTRICULAR OUTFLOW TRACT) VIA THE FEMORAL OR JUGULAR VEIN HAD MODERATE PARAVALVULAR LEAKAGE, WHICH WAS CORRECTED PERCUTANEOUSLY WITH A VASCULAR PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136075 SAPIEN XT TRANSCATHETER HEART VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV EDWARDS LIFESCIENCES 9300TFX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention