BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 23413386 · Received October 29, 2025

    Report

    Report Number
    2015691-2025-08894
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 9, 2025
    Report Date
    December 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    UDI-DI
    00690103213324
    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

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2 AND H6 (COMPONENT 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 LEAFLET DAMAGE DURING CAPTURING WAS CONFIRMED WITH EMPIRICAL EVIDENCE BASED ON INFORMATION PROVIDED. AVAILABLE INFORMATION SUGGESTS PATIENT ANATOMY AND PROCEDURAL FACTORS LIKELY CONTRIBUTED TO THE EVENT. PATIENT PRESENTED WITH A CLEFT-LIKE INDENTATION BETWEEN P2 AND P3, FRAGILE LEAFLETS, PSEUDOPROLAPSE ON THE ANTERIOR MITRAL LEAFLET, AND ECCENTRIC POSTERIORLY DIRECTED JET. DURING THE PROCEDURE, MULTIPLE GRASPING ATTEMPTS WERE MADE WITHOUT SUCCESS AND IT WAS DECIDED TO BAIL OUT THE DEVICE. THEN, A MINOR SUPERFICIAL FISSURE WAS OBSERVED ON PLM. TOGETHER, THESE PATIENT-SPECIFIC AND PROCEDURAL FACTORS MAY HAVE CREATED SUBOPTIMAL CONDITIONS RESULTING IN THE LEAFLET DAMAGE. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.

    Description of Event or Problem · 0

    PER THE REPORT RECEIVED FROM GERMANY, EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION ACE PROCEDURE IN MITRAL POSITION. AFTER BAILING OUT THE DEVICE, A FOCAL DEFECT WAS NOTED IN THE POSTERIOR MITRAL LEAFLET. THE PATIENT HAD MIXED MITRAL REGURGITATION (MR), SEVERITY 4 WITH A CLEFT-LIKE INDENTATION BETWEEN P2 AND P3, FRAGILE LEAFLETS, PSEUDO-PROLAPSE ON THE ANTERIOR MITRAL LEAFLET (AML), AND AN ECCENTRIC POSTERIORLY DIRECTED JET INITIALLY DESCRIBED AS COMPLEX. MULTIPLE UNSUCCESSFUL GRASPING ATTEMPTS WERE TRIED, SO IT WAS DECIDED TO BAIL OUT AS NO MR REDUCTION COULD BE ACHIEVED AND THE TEAM HAD DECIDED TO CONSIDER SURGICAL REPAIR INSTEAD. AFTER BAIL OUT, A LIMITED FOCAL DEFECT WAS NOTED AT THE POSTERIOR MITRAL LEAFLET (P2) PRESENTING AS MINOR SUPERFICIAL FISSURE RATHER THAN A FULL TEAR WITH THE LEAFLET EDGES SHOWING SLIGHT FRAYING. AS PER MEDICAL OPINION, THIS WAS LIKELY CAUSED BY THE REPEATED GRASPING ATTEMPTS WITH THE PASCAL DEVICE. THE INITIAL MR GRADE WAS SEVERE (4), AND IT REMAINED SEVERE POST-PROCEDURE. THE PATIENT WAS IN GOOD CONDITION AND SURGICAL REPAIR OF THE VALVE IS PLANNED. AS REPORTED, THE PROCEDURE WAS ABORTED DUE TO VALVE ANATOMY, NOTHING RELATED TO DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212319 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000ISM 00690103213324

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Other