BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 19763927 · Received July 17, 2024

    Report

    Report Number
    2015691-2024-05413
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 24, 2024
    Report Date
    August 20, 2024
    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 EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4). THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    ADDITIONALLY, IN REGARDS TO THE VALVE REPLACEMENT, THIS PATIENT HAD MIXED PATHOLOGY, A PREVIOUS SURGICAL RING/ ANNULOPLASTY, AND POST ANNULOPLASTY SYSTOLIC ANTERIOR MOTION (SAM). THE MEDICAL TEAM DECIDED TO ATTEMPT PASCAL TEER FIRST, BUT GIVEN THE DEVICE EMBOLIZATION AND RESIDUAL REGURGITATION, THE PATIENT WAS PROPOSED TO HAVE SURGICAL VALVE REPLACEMENT. THE SURGICAL VALVE REPLACEMENT WAS DEEMED NECESSARY AND A BETTER OPTION FOR THIS PATIENT. THE COMPLAINT FOR IMPLANT DETACHES FROM BOTH LEAFLETS INTO VASCULATURE (POST PROCEDURE) WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE AS CONFIRMED BY THE EDWARDS CLINICAL SPECIALIST PRESENT AT THE CASE. AVAILABLE INFORMATION SUGGESTS THAT PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. PATIENT FACTORS INCLUDE THE VERY LONG AML THAT WAS DEEP IN THE VENTRICLE ALONG WITH THE SHORT AND RESTRICTED PML. THE DRASTIC DIFFERENCE IN LENGTH AND MOTION OF LEAFLETS CONTRIBUTED TO THE DIFFICULTY IN SUCCESSFULLY CAPTURING LEAFLET DURING THE PROCEDURE. ADDITIONALLY, PROCEDURAL FACTORS INCLUDED SHADOWED ECHO IMAGING DUE TO A PREVIOUSLY IMPLANTED RING. THIS CREATED CHALLENGES IN IDENTIFYING WHETHER LEAFLET WAS PROPERLY CAPTURED. FURTHERMORE, THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE WERE THREE NONCONFORMANCES ATTRIBUTED TO THIS WORK ORDER, BUT THEY ARE UNRELATED TO THE COMPLAINT EVENT.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF A PASCAL ACE IN MITRAL POSITION WHERE IMMEDIATELY AFTER RELEASE, IT WAS OBSERVED THAT THE POSTERIOR MITRAL LEAFLET (PML) WAS NOT CAUGHT. APPROXIMATELY, TEN MINUTES AFTER SYSTEM REMOVAL, THE DEVICE EMBOLIZED AND REMAINED FLOATING IN THE ABDOMINAL AORTA. THE PATIENT HAD MIXED PATHOLOGY THAT HAD BEEN ALREADY TREATED WITH A RING. THE PATIENT DEVELOPED SYSTOLIC ANTERIOR MOTION (SAM) AND THEREFORE THE DECISION WAS MADE TO REPAIR WITH PASCAL. THERE WAS A LOT OF SHADOWING DUE TO THE RING. THE VALVE WAS RATHER SMALL WITH A VERY LONG ANTERIOR MITRAL LEAFLET (AML) DEEP IN VENTRICLE, A SHORT RESTRICTED PML AND A GRADIENT OF 3 MMHG. IT WAS NOT POSSIBLE TO DO SIMULTANEOUS GRASPING, AS THE FREE EDGES OF BOTH LEAFLETS WERE VERY FAR AWAY. THERE WAS SHADOWING ON THE PML. IT WAS DECIDED TO GO FORWARD WITH THE PROCEDURE USING A P10 DEVICE. SEVERAL STRATEGIES WERE TRIED OUT, BUT NONE OF THEM WAS SUCCESSFUL. THE DECISION WAS MADE TO BAILOUT THE P10 DEVICE AND CHANGE TO AN ACE DEVICE. SAME APPROACHES AS WITH THE P10 DEVICE WERE TRIED WITH THE ACE DEVICE. AGAIN, THE SHADOWING AND THE SHORT PML MADE THE GRASPING DIFFICULT. AT A CERTAIN TIME, IT WAS CONFIRMED THROUGH ECHO THAT THE PML WAS IN, SO THE DEVICE WAS CLOSED. THERE WAS A NICE CHANGE IN THE MITRAL REGURGITATION (MR) GRADE. HOWEVER, THE CLINICAL SPECIALIST EXPRESSED DOUBTS REGARDING THE PML. 3D TRANSGASTRIC VIEW AND ECHOCARDIOGRAPHY WERE CHECKED, AND ECHOCARDIOGRAPHER INSISTED THAT THE PML WAS INSERTED. THE DEVICE WAS THEN RELEASED. IMMEDIATELY AFTER THE PASCAL RELEASE, THROUGH ECHOCARDIOGRAPHY AND FLUOROSCOPY IT WAS OBSERVED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED AS THE PML WAS NOT IN AT ALL. HOWEVER, THE HEMODYNAMICS CHANGED IN POSITIVE WAY AS PASCAL WAS FUNCTIONING AS SORT OF PLUG. THERE WAS REDUCTION IN MR AND THE SAM WAS GONE. THE PASCAL SYSTEM WAS REMOVED AND CLOSURE OF THE GROIN WAS STARTED. APPROXIMATELY 10 MINUTES LATER, THE PASCAL EMBOLIZED AND WAS FLOATING IN THE AORTA ABDOMINAL. THE EMBOLIZED DEVICE WAS REMOVED WITH 2 LASSOS AND A 22FR INTRODUCER. DURING DEBRIEFING, THE IMPLANTING CARDIOLOGIST (IC) MENTIONED THAT IT WAS A DIFFICULT OFF LABEL CASE. ADDITIONALLY, AS PER THE ECHOCARDIOGRAPHER, IT WAS NOT POSSIBLE TO ONLY TREAT THE P2 PROLAPSE. THE HEART TEAM WOULD TALK TO PATIENT AND FAMILY TO PROPOSE MOST LIKELY SURGERY TO FURTHER TREAT THE SAM WITH VALVE REPLACEMENT. IN CASE THE DECISION WOULD BE NOT TO GO FOR SURGERY, PATIENT CONDITIONS WOULD REMAIN AS THEY WERE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED THAT A SURGICAL VALVE REPLACEMENT WAS PERFORMED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351342 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000ISM 00690103213324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention