BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 16638504 · Received March 29, 2023

    Report

    Report Number
    2015691-2023-11948
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    February 6, 2023
    Report Date
    April 5, 2023
    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

    THE FOLLOWING SECTIONS WERE ADDED/UPDATED/CORRECTED: B4, D4, G3, G6, H2, H4, H6 AND H10. THE REPORTED SLDA EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY, AND ONE WAS NOT ABLE TO BE CONFIRMED THROUGH IMAGING REVIEW. THE PRESENCE OF AN SLDA AS DESCRIBED IN THE COMPLAINT EVENT WAS CONFIRMED BY OBJECTIVE EVIDENCE VIA IMAGING EVALUATION. PER THE IMAGING EVALUATION, POSSIBLE CONTRIBUTING FACTORS TO THE SLDA INCLUDE: PROCEDURAL ISSUES (INADEQUATE LEAFLET GRASPING, MISINTERPRETATION, AND MISSING NECESSARY MANEUVERS) AND IMAGING ISSUES (INACCURATE VIEW PLANES, AND NO LEAFLET GRASPING CLIP RECORDED). FURTHERMORE, A DHR REVIEW WAS COMPLETED AND NO NONCONFORMANCES RELATED TO THE COMPLAINT EVENT WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #:(B)(4). 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. 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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF A PASCAL ACE PRECISION PROCEDURE IN TRICUSPID POSITION. PLACEMENT OF FIRST PASCAL ACE PRECISION DEVICE WAS DONE IN A CENTRAL ANTERIOR SEPTAL POSITION WITH 2/8 CLOCKING. THERE WAS INDEPENDENT GRASPING STARTING WITH LATERAL IN TG SAX AND SEPTAL IN RV INFLOW OUTFLOW X- PLANE. THE GRASPING WAS CHECKED IN BOTH VIEWS- LATERAL LOOKED SUFFICIENT, SEPTAL WAS DECIDED TO OPTIMIZE IN RV INFLOW OUTFLOW X-PLANE. HEALTH CARE PROFESSIONAL (HCP) UNEXPECTEDLY CHECKED SEPTAL INSERTION AFTER OPTIMIZATION BY ADVANCING IC INTO RV. SEPTAL LEAFLET HAD A GOOD GRASP AND THE HCP DECIDED TO RELEASE. FIRST SEPTAL CLASP SUTURE WAS PULLED OUT AND DURING PULL OUT OF LATERAL CLASP SUTURE, DETACHMENT OF ANTERIOR LEAFLET WAS NOTICED. DECISION WAS MADE TO IMPLANT A SECOND PASCAL ACE PRECISION DEVICE ANTERIOR OF FIRST ONE TO STABILIZE IT. THERE WAS SUCCESSFUL IMPLANTATION OF SECOND IMPLANT ANTERIOR SEPTAL IN 2/8 CLOCKING. FINAL RESULT WAS TR 4 AND PATIENT WAS STABLE. AFTER IMAGE EVALUATION REVIEW, THERE APPEARED TO BE AN ACUTE/INTRA-PROCEDURAL SLDA OF THE FIRST PASCAL ACE DEVICE IN THE PROCEDURAL TEE. THERE WERE TWO PASCAL ACE DEVICES DEPLOYED. THE SECOND ACE DEVICE APPEARED TO BE IN A STABLE POSITION. THE 3RD ACE DEVICE APPEARED SUCCESSFULLY BAILED OUT. FINAL RESIDUAL TR APPEARED SEMI-QUANTITATIVELY, 3 - SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306720 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000ISM 10315967 00690103213324

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other