BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 19975755 · Received August 13, 2024

    Report

    Report Number
    2015691-2024-06086
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 18, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217520
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2, H6 AND H11. THE COMPLAINT FOR DELIVERY SYSTEM AND/OR GUIDEWIRE PUSHED INTO VENTRICULAR WALL WAS CONFIRMED WITH OTHER EMPIRICAL EVIDENCE BY THE INFORMATION PROVIDED BY EDWARDS CLINICAL SPECIALIST. NO IMAGING WAS PROVIDED TO SUPPORT INVESTIGATION AND NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED IN THE INFORMATION PROVIDED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    THE EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4). THE MANUFACTURER'S INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE IT WAS REPORTED THE SAFARI WIRE WAS PLACED USING A COMPETITOR'S STEERABLE SHEATH AND NO PIGTAIL WAS USED DURING WIRE PLACEMENT. THERE WAS NO DIFFICULTY WITH DELIVERY SYSTEM INSERTION THROUGH IVC, BUT DURING DELIVERY SYSTEM CROSSING, THE PATIENT BECAME HYPOTENSIVE AND INSTABLE IMMEDIATELY AFTER A NOTICEABLE FLIP OF THE WIRE CURL WAS SEEN ON FLUORO. ONCE IT WAS SEEN, THE WIRE WAS IMMEDIATELY PULLED BACK. THE STRUCTURAL HEART TEAM QUICKLY SAW THAT THE PATIENT HAD A PERICARDIAL EFFUSION. 400-500ML OF BLOOD WAS DRAWN OUT OF THE PERICARDIAL SACK WITHOUT ATTAINING PATIENT STABILITY. THE DECISION WAS MADE TO OPEN THE PATIENT AND REPAIR IMMEDIATELY. A SEMI-RIGID MC ANNULOPLASTY RING WAS PLACED IN THE TRICUSPID VALVE (IT WAS NOTED THAT THE TISSUE WAS "FALLING APART" AND IT WAS "CHALLENGING TO IMPLANT THE SEMI-RIGID MC ANNULOPLASTY RING"). THE 2-3CM HOLE WAS ALONG THE FREE WALL; IT WAS NOT DIRECTLY IN THE RV APEX, AND WAS FIXED SURGICALLY. THE SURGERY WAS SUCCESSFUL AND THE PATIENT DIDN'T LOSE PERFUSION TO VITAL ORGANS DURING THEIR INSTABILITY. THE PATIENT IS CURRENTLY RECOVERING IN THE HOSPITAL. FURTHER INVESTIGATION CONFIRMED THAT THE PATIENT WAS ON CHRONIC STEROID USE AND THE TISSUE WAS NOTED TO BE FRIABLE. THE INTERVENTIONAL CARDIOLOGIST EXPRESSED THAT THE STEROID USE DEFINITELY HAD A FACTOR IN TISSUE FRIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094974 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850TDSUS 65489867 00690103217520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H