BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 21607421 · Received March 14, 2025

    Report

    Report Number
    2015691-2025-01940
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 21, 2025
    Report Date
    April 16, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    UDI-DI
    00690103213331
    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

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2, H6 AND H11. THE COMPLAINT FOR DIFFICULT/UNABLE TO INSERT DEVICE INTO TRANSSEPTAL PUNCTURE LOCATION WAS CONFIRMED WITH EMPIRICAL EVIDENCE BASED ON INFORMATION PROVIDED BY EDWARDS CLINICAL SPECIALIST WHO WAS PRESENT ON THE SITE. 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. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED. AS RELEVANT IMAGERY WAS NOT PROVIDED, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. HOWEVER, AVAILABLE INFORMATION SUGGESTS PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT HAD PATENT FORAMEN OVALE (PFO). THE PFO AND THE INSERTION OF THE GUIDE SHEATH (GS) THROUGH THE SECOND TRANSSEPTAL PUNCTURE COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    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

    PER REPORT RECEIVED FROM GERMANY- EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION ACE PROCEDURE IN MITRAL POSITION WHERE AFTER PULLING OUT THE GUIDE SHEATH (GS), A RIGHT LEFT SHUNT WAS VISIBLE IN ECHO. SEPTAL DEFECT DIAMETER WAS 30MM. PATIENT WAS HEMODYNAMICALLY STABLE ALL THE TIME, HOWEVER, THE MEASURED OXYGEN SATURATION DROPPED A LITTLE BIT FROM 98 TO 89. THE PHYSICIAN IMPLANTED A 32 F LIFETEC ASD OCCLUDER WITHOUT ANY ISSUES. THERE WAS NO SHUNT VISIBLE AFTERWARDS. THE PATIENT ALREADY HAD PATENT FORAMEN OVALE (PFO). THE FIRST TSP PUNCTURE WAS TOO HIGH (> 6,5CM) THEREFORE, A SECOND PUNCTURE WAS PERFORMED. TWO PASCAL PRECISION ACE DEVICES WERE IMPLANTED AFTERWARDS WITHOUT ANY ISSUES. AFTER PULLING OUT THE GS IS WHEN THE EVENT WAS NOTICED. AS PER PHYSICIAN'S OPINION, THE FIRST TRANSSEPTAL PUNCTURE, THE PFO AND THE INSERTION OF THE GS THROUGH THE SECOND TRANSSEPTAL PUNCTURE COULD HAVE ALL RESULTED IN THE ASD. BUT THERE WAS NO MALFUNCTION OF THE GS, OR ANY OTHER EDWARDS DEVICE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228136 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GS 65882122 00690103213331

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention