BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 21833480 · Received April 14, 2025

    Report

    Report Number
    2015691-2025-02871
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    February 21, 2025
    Report Date
    May 23, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    PMA / PMN Number
    P220003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: LAI LKL, ALRAYES H, FRAM G, LEE JC, ZWEIG B, O'NEILL BP, FRISOLI TM, GONZALEZ PE, O'NEILL WW, VILLABLANCA PA. IATROGENIC ATRIAL SEPTAL DEFECT CLOSURE WITH PASCAL GUIDE SYSTEM POST-MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR. J INVASIVE CARDIOL. 2025 FEB 21. DOI: 10.25270/JIC/25.00031. EPUB AHEAD OF PRINT. PMID: 39993275. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL H6 TYPE OF INVESTIGATION CODE: 'ANALYSIS OF IMAGES' AND 'LABELLING REVIEW'. THE COMPLAINT FOR DIFFICULT/UNABLE TO INSERT DEVICE INTO TRANSSEPTAL PUNCTURE LOCATION WAS UNABLE TO BE CONFIRMED. NO DEVICE WAS RETURNED FOR EVALUATION. AN IMAGE OF THE ATRIAL SEPTAL DEFECT COULD BE FOUND IN THE JOURNAL ARTICLE ALLEGING THE EVENT. OTHER IMAGES INCLUDED IN THE ARTICLE ARE RELATED TO THE STEPS TAKEN TO REPAIR THE SEPTAL DEFECTS RATHER THAN THE PASCAL PROCEDURE. IT IS UNCLEAR IF THE ATRIAL SEPTAL DEFECT WAS A RESULT OF INSERTING THE DEVICE INTO THE TRANSSEPTAL PUNCTURE LOCATION OR IF THERE ARE OTHER POTENTIAL PROCEDURAL STEPS IT COULD HAVE OCCURRED AT AS THERE ARE FEW DETAILS ON THE PASCAL PROCEDURE PROVIDED IN THE ARTICLE. THE ATRIAL SEPTAL DEFECT WAS NOTED TO BE FOUND POST-PROCEDURE AND THERE WAS NO ALLEGATION OF DIFFICULTIES INSERTING THE DEVICE INTO THE TRANSSEPTAL PUNCTURE LOCATION. NO DEVICE LOT INFORMATION WAS PROVIDED THEREFORE, A DEVICE HISTORY RECORD REVIEW AND A LOT HISTORY REVIEW COULD NOT BE COMPLETED. PER THE INSTRUCTIONS FOR USE (IFU), ATRIAL / SEPTAL WALL DAMAGE AND PERICARDIAL EFFUSION IS A KNOWN POTENTIAL ADVERSE EVENT WHICH HAVE BEEN IDENTIFIED AS A POSSIBLE COMPLICATION OF MITRAL AND TRICUSPID VALVE REPAIR, INCLUDING THE PASCAL IMPLANT PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO SUCH INJURY. POOR TRANSEPTAL PUNCTURE (TSP) LOCATION AND OR ANATOMICAL CHALLENGES CAN BE TWO COMMON FACTORS THAT CAN CAUSE THESE TYPES OF EVENTS. THE PASCAL TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE TSP. PHYSICIANS ARE TRAINED BY EDWARDS TEAM MEMBERS BEFORE THEY ARE QUALIFIED TO USE THE PASCAL SYSTEM. TRAINING INCLUDES PATIENT SCREENING (TO ENSURE ANATOMY IS SUITABLE FOR THE DEVICE), DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY IN CONJUNCTION WITH ECHOCARDIOGRAPHY FOR OPTIMAL VISUALIZATION DURING POSITIONING AND DEPLOYMENT OF THE DEVICE. IN THIS CASE, THERE IS VERY LITTLE INFORMATION ON THE PASCAL PROCEDURE THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE PATIENT SUCCESSFULLY UNDERWENT INTRACARDIAC ECHOCARDIOGRAPHY-GUIDED MITRAL VALVE TEER USING 1 PASCAL P10 DEVICE AND 2 PASCAL ACE DEVICES. POST-PROCEDURE, A 1.2-CM IASD WITH A BIDIRECTIONAL SHUNT AND OXYGEN DESATURATION WAS IDENTIFIED. URGENT CLOSURE WAS PERFORMED USING A 22-MM AMPLATZ ASD OCCLUDER (ABBOTT). THE PASCAL GUIDE SHEATH WAS RE-CROSSED TO THE LEFT ATRIUM USING A DILATOR OVER AN AMPLATZ SUPER STIFF WIRE (BOSTON SCIENTIFIC). AFTER REMOVING THE DILATOR AND WIRE, A 9-FR FEMORAL SHEATH WAS ADVANCED INTO THE GUIDE SHEATH TO PASS ITS SEALING VALVE. THE 22 MM AMPLATZ ASD DEVICE WAS THEN LOADED INTO THE 9 FR SHEATH AND ADVANCED. THE LOADER WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092532 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GS

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention