BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 24595456 · Received March 13, 2026

    Report

    Report Number
    2015691-2026-13193
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    May 1, 2016
    Report Date
    April 16, 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

    THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM MAY 2016 AND OCTOBER 2022. THEREFORE, MAY 1, 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. INVESTIGATION IS ONGOING. 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 VIA THE FEMORAL OR JUGULAR VEIN DEVELOPED A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) RUPTURE WITHOUT HEMODYNAMIC COMPROMISE. THE RUPTURE WAS SUCCESSFULLY SEALED PERCUTANEOUSLY WITH A COVERED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32470 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