BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM

    MDR report key: 20189596 · Received September 11, 2024

    Report

    Report Number
    2015691-2024-06985
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 15, 2024
    Report Date
    November 12, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPW
    UDI-DI
    00690103217520
    PMA / PMN Number
    P230013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    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 OBJECTIVE EVIDENCE VIA IMAGING EVALUATION. AVAILABLE INFORMATION FROM A CALL WITH EDWARDS CLINICAL SPECIALIST SUGGESTS THAT PROCEDURAL ISSUES RELATED TO EXCESSIVE MANIPULATION OF THE DELIVERY SYSTEM LIKE SNARING WITHOUT SUFFICIENT GUIDEWIRE RETRACTION MIGHT HAVE CONTRIBUTED TO THE EVENT, HOWEVER A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED. NO MANUFACTURING NON-CONFORMITIES WERE FOUND IN THE RETURNED SAMPLE OR IDENTIFIED FROM THE IMAGING EVALUATION. SINCE NO MANUFACTURING NON-CONFORMANCES WERE FOUND AND NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, NO PRA REQUIRED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID PROCEDURE WHERE THERE WAS A WIRE PERFORATION PRIOR TO CAPSULE GAP. THE PATIENT WAS THEN TRANSPORTED TO SURGERY. THE PROCEDURE WAS ABORTED AFTER INSERTION AND THE TR (TRICUSPID REGURGITATION) GRADE PRE-PROCEDURE AS WELL AS POST-PROCEDURE WAS THE SAME AT SEVERE 3+. AS PER INTERNAL IMAGING REVIEW, A LARGE PERICARDIAL EFFUSION WAS CONFIRMED IN BOTH THE PROCEDURE AND SURGICAL TEE DATED (B)(6) 2024. INTRA-OP FLUOROSCOPY IMAGING SUGGESTS POTENTIAL GUIDEWIRE PRESSURE AFTER SNARING OF THE DELIVERY SYSTEM. THE PATIENT SUBSEQUENTLY UNDERWENT SURGERY TO REPAIR THE RV PERFORATION SITE AND HAD A TRICUSPID VALVE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567211 EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES NPW EDWARDS LIFESCIENCES 9850TDSUS 65706410 00690103217520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention