BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 24210211 · Received January 29, 2026

    Report

    Report Number
    2015691-2026-10636
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 17, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    UDI-DI
    00690103216967
    PMA / PMN Number
    P220003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, D4, G3, G6, H2, H4, H6, AND H11. H6 TYPE OF INVESTIGATION: LABELLING REVIEW. THE COMPLAINT FOR INABILITY OR DIFFICULTY TO INSERT DEVICE INTO TRANSSEPTAL PUNCTURE LOCATION WAS CONFIRMED. AVAILABLE INFORMATION SUGGESTS DURING THIS MITRAL PROCEDURE A PERICARDIAL EFFUSION WAS NOTICED WHICH PROGRESSED TO CARDIAC TAMPONADE AND THERE WAS NO EFFUSION / CARDIAC TAMPONADE NOTED BEFORE THE INSERTION OF THE GS. THROUGH THE PROCEDURE THERE WAS DIFFICULT IMAGING THROUGHOUT THE CASE AND DIFFICULTIES NOTED DURING DEVICE INSERTION. BOTH FACTORS COULD HAVE CONTRIBUTED TO PUNCTURING OF THE ATRIAL WALL DURING THE TRANSEPTAL PUNCTURE THOUGH THIS WAS UNABLE TO BE CONFIRMED. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION, ALTHOUGH THE PROCEDURE HAD TO BE ABORTED FOR SURGICAL INTERVENTION TO REMOVE THE CLOTTED MATERIAL. IN THIS SPECIFIC EVENT, IT IS NOT POSSIBLE TO IDENTIFY WHAT EXACTLY LEAD TO THE EFFUSION. 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.

    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

    EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THE IMPLANT WAS OPENED BUT NOT ATTEMPTED. DURING THE PROCEDURE, WHEN THE GS (GUIDE SHEATH) WAS INTRODUCED AND THE PASCAL DEVICE INTRODUCED INTO THE GS, A PERICARDIAL EFFUSION WAS NOTICED WHICH PROGRESSED TO CARDIAC TAMPONADE. THERE WAS NO EFFUSION / CARDIAC TAMPONADE NOTED BEFORE THE INSERTION OF THE GS. DURING TRANSSEPTAL PROCEDURE, THE WIRE WAS NOTED AS DIFFICULT TO ADVANCE, AND THE TEAM COULD NOT CONFIRM WHERE THEY WERE (LUPV VS RUPV). IMAGING WAS ALSO DIFFICULT AS IC WAS INSTRUCTED TO GO MORE POSTERIOR, AND A PUNCTURE WAS MADE THROUGH THE SEPTAL TRIGONE. PERICARDIOCENTESIS WAS PERFORMED. PATIENT WAS THEN SURGICALLY OPENED, AND IN SURGERY, BLEEDING HAD STOPPED REQUIRING NO SURGICAL REPAIR, ONLY EVACUATION OF THE CLOTTED MATERIAL. THE PASCAL PROCEDURE WAS ABORTED. THE MR (MITRAL REGURGITATION) REMAINED SEVERE. THE PATIENT IS STABLE. A PLAN FOR REINTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276544 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GSA 67205003 00690103216967

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention