BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 23657375 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09589
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 29, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    PMA / PMN Number
    P220003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION ADDED/UPDATED TO SECTION B4, G3, G6, H2, AND H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATIONS CONCLUSIONS). H11: ADDITIONAL MANUFACTURER NARRATIVE: THE COMPLAINT FOR THROMBUS FORMATION DURING PROCEDURE WAS CONFIRMED WITH EMPIRICAL EVIDENCE BASED ON INFORMATION PROVIDED. AS PER MEDICAL ARTICLE, SHORTLY AFTER ADVANCING THE STEERABLE GUIDE CATHETER, A MOBILE, THREAD-LIKE ECHOGENIC MASS (APPROXIMATELY 60 X 4 MM), CONSISTENT WITH ACUTE THROMBUS, INITIALLY ADHERENT TO THE CATHETER TIP. WITHIN SECONDS, IT DETACHED AND MIGRATED TO THE POSTERIOR TRICUSPID LEAFLET". BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE IS INDETERMINABLE. THE COMPLAINT REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE, AS NO ADEQUATE IMAGING AVAILABLE, NO PRODUCT RETURN AND NO ADDITIONAL INFORMATION FROM THE SITE. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    G2: REPORT SOURCE - NAPPA, D., SALIDO-TAHOCES, M. L., GARCIA-MARTIN, A., SANCHEZ-RECALDE, A., & FERNANDEZ-GOLFLIN, C. (2025). ACUTE TRICUSPID LEAFLET THROMBUS DURING TRANSCATHETER TRICUSPID VALVE REPAIR. JACC: CASE REPORTS, 105944. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. IT SHOULD BE NOTED; THE DEVICE WAS IMPLANTED IN THE TRICUSPID POSITION. AT THIS TIME, THE PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM IS ONLY INDICATED FOR THE NATIVE MITRAL VALVE IN THE US, ADDRESSING DEGENERATIVE MITRAL REGURGITATION. BUT, IT IS APPROVED FOR BOTH TRICUSPID AND MITRAL SPACES IN THE REGION WHERE THE PROCEDURE WAS PERFORMED. THEREFORE, DEPLOYMENT IN THE TRICUSPID POSITION WILL NOT BE CONSIDERED OFF-LABEL IN THIS CASE.

    Description of Event or Problem · 0

    AS PER MEDICAL ARTICLE RECEIVED FROM ITALY, "ACUTE TRICUSPID LEAFLET THROMBUS DURING TRANSCATHETER TRICUSPID VALVE REPAIR" CORRESPONDING AUTHOR DR DALILA NAPPA ET AL. EDWARDS RECEIVED NOTIFICATION OF PASCAL PROCEDURE IN TRICUSPID POSITION. DURING THE PROCEDURE A THROMBUS WAS NOTICED AT THE CATHETER TIP. PATIENT HAD ATRIAL FIBRILLATION WITH CONTROLLED VENTRICULAR RESPONSE. IN ACCORDANCE WITH GUIDELINES, APIXABAN WAS WITHHELD 24 HOURS BEFORE THE PROCEDURE. AFTER CATHETER INTRODUCTION INTO THE RIGHT ATRIUM, UNFRACTIONATED HEPARIN WAS ADMINISTERED, TARGETING AN ACTIVATED CLOTTING TIME (ACT) > 250 SECONDS. THE INITIAL ACT WAS CONFIRMED AT 250 SECONDS. SHORTLY AFTER ADVANCING THE STEERABLE GUIDE CATHETER, BOTH TEE AND ICE REVEALED A MOBILE, THREAD-LIKE ECHOGENIC MASS (APPROXIMATELY 60X4 MM) CONSISTENT WITH ACUTE THROMBUS, INITIALLY ADHERENT TO THE CATHETER TIP. WITHIN SECONDS, IT DETACHED AND MIGRATED TO THE POSTERIOR TRICUSPID LEAFLET. ADDITIONAL HEPARIN BOLUSES WERE ADMINISTERED, INCREASING THE ACT TO 280 SECONDS, HOWEVER THE THROMBUS REMAINED ADHERENT TO THE POSTERIOR TRICUSPID VALVE LEAFLET. GIVEN ITS SIZE, MOBILITY, AND EMBOLIC RISK, THE TEAM PROCEEDED WITH THROMBUS ASPIRATION. RIGHT COMMON FEMORAL VEIN WAS CANNULATED WITH AN 8.5-F SHEATH (ABBOTT), WHICH WAS ADVANCED THROUGH THE RIGHT ATRIUM TO TRICUSPID VALVE LEAFLETS, GUIDED BY TEE. MANUAL ASPIRATION THROMBECTOMY WAS PERFORMED USING A 60-ML SYRINGE, RESULTING IN SUCCESSFUL THROMBUS REMOVAL, WITHOUT EMBOLIC OR STRUCTURAL COMPLICATIONS, CONFIRMED BY IMMEDIATE IMAGING. TWO PASCAL DEVICES WERE IMPLANTED WITH A TRICUSPID REGURGITATION REDUCTION FROM SEVERE TO MILD. NO RESIDUAL THROMBUS OR DEVICE-RELATED COMPLICATIONS WERE NOTED. ON POD#3 PATIENT WAS DISCHARGED. AT 30-DAYS FOLLOW UP PATIENT WAS ASYMPTOMATIC (NYHA FUNCTIONAL CLASS I), WITH NO SIGNS OF VOLUME OVERLOAD. TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED BOTH DEVICES IN STABLE POSITION, WITH MILD RESIDUAL TR AND NO EVIDENCE OF THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030254 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000ISM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention