BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASCAL PRECISION SYSTEM

    MDR report key: 16000483 · Received December 16, 2022

    Report

    Report Number
    2015691-2022-10089
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 30, 2022
    Report Date
    January 26, 2023
    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 EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: 2022-22506-01. 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 EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4). THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, D4, G3, G6, H2, H3, H6, AND H10. H10: A SUPPLEMENTAL MDR IS SUBMITTED BASED ON THE MANUFACTURER'S FINAL INVESTIGATION. THE COMPLAINT FOR INADEQUATE ASPIRATION AND AIR REMAINING IN THE DEVICE DURING INSERTION WAS CONFIRMED WITH OBJECTIVE EVIDENCE. AIR BUBBLES WERE VISUALIZED IN THE ATRIUM VIA EVALUATION OF RETURNED IMAGING, AND THE PRESENCE OF AIR IS A POTENTIAL CAUSE FOR EKG CHANGES. THE COMPLAINT WAS CONFIRMED. HOWEVER, A DHR REVIEW OF THE LOT IN QUESTION REVEALED NO NON-NONCONFORMANCES. EVALUATION OF RETURNED IMAGING SHOWED NO EVIDENCE OF DEVICE-RELATED ISSUES OR MALFUNCTIONS. REPRESENTATIVE UNITS FROM A SIMILAR COMPLAINT WERE UTILIZED TO ASSESS THE PROCEDURAL STEPS INDICATED IN THE EVENT DESCRIPTION. THE UNITS WERE PREPPED PER THE EVENT DESCRIPTION BEFORE INSERTING INTO A PRESSURIZED HEMOSTASIS CHAMBER. THE UNIT WAS THEN ASPIRATED AND MANEUVERED PER THE EVENT DESCRIPTION, AND ANY ESCAPED AIR WAS COLLECTED AND MEASURED. AFTER THREE (3) TEST TRIALS, THE MEASURED VOLUMES OF AIR FELL WITHIN THE RANGE OF HISTORICAL DESIGN VERIFICATION DATA. THE INVESTIGATION FINDINGS DID NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. NO PROCEDURAL OR DEVICE-RELATED ISSUES COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION PROCEDURE IN THE MITRAL POSITION. THE GUIDE SHEATH (GS) AND IMPLANT SYSTEM (IS) WERE PREPARED ACCORDING TO THE IFU. THE IS WAS INSERTED INTO THE GS 10 CM, THE LOADER PULLED BACK, AND THE ASPIRATION OF 45ML BLOOD. THE GS WAS FLUSHED WITH 45 ML HEPARINIZED SALINE. FURTHER INSERTION OF THE IS UNTIL THE PASCAL TIP WAS JUST OUT OF GS. ST-ELEVATION WAS NOTED IN ALL LEADS OF THE THREE LEAD ECGS, AND THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. POSTERIOR LV WALL REDUCED MOVEMENT OBSERVED ON ECHO. ATROPINE WAS ADMINISTERED. NO AIR WAS VISIBLE IN THE ECHO. AFTER FIVE MINUTES, THE ST ELEVATION GRADUALLY DECREASED AND WAS RESOLVED. THE PATIENT'S HEMODYNAMICS WAS NORMALIZED. THE PHYSICIAN DECIDED TO CONTINUE WITH THE IMPLANT PROCEDURE WITHOUT CHANGING THE GS OR IS. THE FOLLOWING IMPLANT PROCEDURE WAS SUCCESSFUL, WITH NO OTHER UNANTICIPATED EVENTS. THE PATIENT SHOWED NO NEGATIVE EFFECTS AFTER THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192520 PASCAL PRECISION SYSTEM MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GS 00690103213331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention