BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 20845214 · Received December 4, 2024

    Report

    Report Number
    2015691-2024-09125
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 13, 2024
    Report Date
    February 11, 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

    PROCEDURAL IMAGING WAS PROVIDED FOR EVALUATION. INTERNAL IMAGING REVIEW REVEALED THE FIRST GUIDE SHEATH (GS) WAS ADVANCED 3 CM INTO THE LA. SIGNIFICANT AMOUNT OF AIR BUBBLES WAS SEEN AFTER THE GS WAS ACROSS THE INTER-ATRIAL SEPTUM (IAS). THE AIR APPEARED TO ORIGINATE FROM THE TIP OF THE FIRST GS AND FLOWED IN INTERMITTENT BURSTS. THE CLUSTERS OF AIR BUBBLES DISPERSED WITH A SWIRLING MOTION AND FILLED MOST OF THE LEFT ATRIUM CHAMBER. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, D4, D9, G3, G6, H2, H3, H6 AND H11. THE COMPLAINT FOR INADEQUATE ASPIRATION, AIR REMAINING IN DEVICE DURING INSERTION WAS CONFIRMED WITH OBJECTIVE EVIDENCE BASED ON THE EVALUATION OF THE RETURNED IMAGING. A DHR REVIEW OF THE LOT IN QUESTION REVEALED NO NON-NONCONFORMANCES RELATED TO THE EVENT. NO DEFECTS, DAMAGE, OR LEAKS WERE NOTED UPON EVALUATION OF RETURNED COMPLAINT UNIT. ANOTHER GUIDE SHEATH USED DURING THE EVENT WAS ALSO RETURNED AND UNDERWENT A DEVICE EVALUATION WITH NO MANUFACTURING NON-CONFORMANCES IDENTIFIED. FOLLOW-UP COMMUNICATIONS WITH THE CLINICAL SPECIALIST REVEALED NO IDENTIFIABLE USE ERRORS OR POTENTIAL DEFECTS WITH EITHER DEVICE. POTENTIAL ROOT CAUSES FOR THE PRESENCE OF AIR MAY INCLUDE: - OMISSION OF A FLUSHING/DE-AIRING STEP OR ERRORS IN PERFORMING STEPS - IMPROPER STOPCOCK/SYRINGE TECHNIQUE HOWEVER, A TRUE ROOT CASE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    PER THE REPORT RECEIVED FROM GERMANY, DURING A PASCAL PRECISION ACE PROCEDURE IN MITRAL POSITION, SMALL BUBBLES WERE VISIBLE IN THE PATIENT'S LEFT ATRIUM (LA). THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND NO ISSUES WERE NOTED DURING DEVICE PREPARATION. THE TRANS-SEPTAL PUNCTURE WAS DIFFICULT, BUT THE GUIDE SHEATH (GS) WAS INSERTED WITHOUT ANY ISSUES. THE GUIDEWIRE AND THE INTRODUCER WERE RETRACTED, AND THE ACE DEVICE WAS INSERTED USING A WATER BRIDGE. THE GS WAS ASPIRATED AND ELEVATED DURING INSERTION, AND WAS ASPIRATED (50ML) WITHOUT ISSUES. AFTER CLOSING THE DEVICE, SMALL BUBBLES LIKE A SNOWSTORM WERE VISIBLE IN THE LA. IT STOPPED IMMEDIATELY AGAIN. THE PATIENT WAS HEMODYNAMICALLY STABLE, THEREFORE THE PROCEDURE CONTINUED. WHILE STEERING TOWARDS THE VALVE, BUBBLES WERE BRIEFLY VISIBLE AGAIN, BUT THE PATIENT REMAINED STABLE. THE ANGLE OF THE IMPLANT WAS NOT OPTIMAL (AORTA-HUGGER), THEREFORE THE DECISION WAS MADE TO BAILOUT THE SYSTEM AND PERFORM ANOTHER TRANS-SEPTAL PUNCTURE. NO VISIBLE DAMAGE WAS OBSERVED ON THE GS. A NEW TRANSSEPTAL PUNCTURE WAS PERFORMED, AND A NEW GS THAT WAS INSERTED WITHOUT ISSUES. THE ACE DEVICE WAS INSERTED AND ASPIRATED WITH NO PROBLEMS. WHEN THE ACE WAS STEERED DOWN TO THE MITRAL VALVE, A COLLECTION OF BUBBLES WAS NOTED IN THE POSTERIOR/MEDIAL LEFT ATRIAL ROOF. AN ATTEMPT TO ASPIRATE THE BUBBLES WITH A PIGTAIL CATHETER THROUGH THE LEFT GROIN ACCESS WAS UNSUCCESSFUL. HOWEVER, THE PROCEDURE WAS CONTINUED AS THE PATIENT REMAINED STABLE. DURING THE FINAL GRASP, BUBBLES WERE VISIBLE AGAIN, BUT MEDICATION HAD BEEN INJECTED. FINALLY, THE ACE WAS IMPLANTED. THE INITIAL MITRAL REGURGITATION (MR) GRADE WAS 4, AND IT WAS 2 POST-PROCEDURE. AFTER THE PROCEDURE, NO AIR WAS VISIBLE ANYMORE IN THE LEFT ATRIAL ROOF. THE PATIENT EXPERIENCED NO SYMPTOMS AND HAD NO NEUROLOGIC SEQUELAE. ACCORDING TO MEDICAL OPINION, THE AMOUNT OF AIR OBSERVED WAS MORE THAN USUAL FOR A TEER PROCEDURE AND ORIGINATED FROM THE FIRST GS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977220 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GS 65711859 00690103213331

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention