BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 23390358 · Received October 27, 2025

    Report

    Report Number
    2015691-2025-08812
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 11, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NMK
    UDI-DI
    00690103213324
    PMA / PMN Number
    P220003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, B5, D4, G3, G6, H2, H4 AND H6 (COMPONENT CODE, CLINICAL CODE, DEVICE CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). H11: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO NONCONFORMANCES RELATED TO THE COMPLAINT EVENT WERE IDENTIFIED. THE COMPLAINT FOR IMPLANT DISLODGED FROM A SINGLE LEAFLET, SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AFTER PROCEDURE WAS CONFIRMED OBJECTIVELY BASED ON RETURNED INTRA-PROCEDURAL IMAGING. AVAILABLE INFORMATION SUGGESTS ECHOGRAPHY IMAGING ISSUES LIKELY CONTRIBUTED TO THE EVENT. AS PER INFORMATION RECEIVED, PROBABLY BAD IMAGE COULD CONTRIBUTE TO THE SLDA. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    B2: OTHER SERIOUS- EVEN THOUGH THERE WAS NO REINTERVENTION, THERE IS A POTENTIAL FOR REINTERVENTION IN THIS CASE. 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. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    AS PER NEW INFORMATION, DURING THE PROCEDURE THERE WAS DIFFICULTY WITH THE ECO IMAGES. THE TRICUSPID REGURGITATION (TR) WAS REDUCED FROM 4 TO 1. AFTER THE PROCEDURE ONE PASCAL DEVICE DETACHED AND THE RESIDUAL TR WAS 3 (SEVERE). THE PATIENT WAS SCREENED FOR TRANSCATHETER TRICUSPID VALVE BUT WAS NOT SUITABLE FOR IT DUE TO MINIMAL DIMENSIONS BEING UNDER 30MM. THE PATIENT WAS NOTED AS DISCHARGED AS PER MEDICAL OPINION THE ROOT CAUSE OF THE SLDA IS PROBABLY TO THE BAD IMAGE QUALITY.

    Description of Event or Problem · 0

    AS PER THE REPORT RECEIVED FROM SPAIN, EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION PROCEDURE IN TRICUSPID POSITION WHERE TWO PASCAL DEVICES WERE IMPLANTED. AFTER AN UNKNOWN IMPLANT DURATION, IT HAS BEEN DETECTED THAT ONE PASCAL DEVICE IS DETACHED AND THE RESIDUAL TR IS SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427842 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NMK EDWARDS LIFESCIENCES 20000ISM 00690103213324

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other