BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 18326738 · Received December 14, 2023

    Report

    Report Number
    2015691-2023-18368
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    December 4, 2023
    Report Date
    January 30, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: 2023-27918-06 THE DEVICE WAS USED IN OFF-LABEL IMPLANTATION IN THE TRICUSPID POSITION. AS THERE ARE NO SPECIFIC IFU OR TRAINING MATERIALS RELATED TO THE PROCEDURE, THE AVAILABLE TRAINING MATERIALS WERE REVIEWED ONLY FOR INFORMATION POTENTIALLY RELEVANT TO THE DEVICE USE. PER THE INSTRUCTIONS FOR USE (IFU), NON-EMERGENT REOPERATION, EMERGENCY CARDIAC SURGERY, REOPERATION, DEVICE MIGRATION OR MALPOSITION REQUIRING INTERVENTION AND DEVICE EXPLANT ARE LISTED AS POTENTIAL RISKS ASSOCIATED WITH THE DEVICE AND TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THE IFU CAUTIONS THAT LONG-TERM DURABILITY HAS NOT BEEN ESTABLISHED FOR THE VALVE. REGULAR MEDICAL FOLLOW-UP IS ADVISED TO EVALUATE VALVE PERFORMANCE. ACCELERATED DETERIORATION OF THE VALVE DUE TO CALCIFIC DEGENERATION MAY OCCUR IN CHILDREN, ADOLESCENTS, OR YOUNG ADULTS AND IN PATIENTS WITH AN ALTERED CALCIUM METABOLISM. VALVE RECIPIENTS SHOULD BE MAINTAINED ON ANTICOAGULANT/ANTIPLATELET THERAPY, EXCEPT WHEN CONTRAINDICATED, AS DETERMINED BY THEIR PHYSICIAN. THIS DEVICE HAS NOT BEEN TESTED FOR USE WITHOUT ANTICOAGULATION. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. VALVE REINTERVENTION MAY BE DUE TO VALVE DYSFUNCTION (E.G., SEVERE OR CLINICALLY SIGNIFICANT PARAVALVULAR LEAK, CENTRAL LEAK, SIGNIFICANT MALPOSITION, EARLY/LATE ENDOCARDITIS, THROMBOSIS, STRUCTURAL VALVE DETERIORATION OR DEGENERATION) AND/OR OTHER REASONS UNRELATED TO THE EDWARDS DEVICES (E.G., TREATMENT OF OTHER PATIENT COMORBIDITIES). DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES (ALL MODELS) ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. IN THIS CASE, IT WAS NOT POSSIBLE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS EVENT AS IT WAS RECEIVED FROM THV/TVT REGISTRY WHICH DOES NOT PROVIDE IDENTIFIABLE INFORMATION. DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NUMBER. 2015691-2023-18361, 2015691-2023-18363, 2015691-2023-18365, 2015691-2023-18366, 2015691-2023-18367, 2015691-2023-18368, 2015691-2023-18369.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION OF AN EVENT THAT FELL OUT OF THE TVT REGISTRY CRITERIA. A 61YEAR-OLD MALE PATIENT WITH A 29 MM SAPIEN 3 XT VALVE IN THE TRICUSPID POSITION REQUIRED TRICUSPID VALVE RE-INTERVENTION APPROXIMATELY 2 MONTHS AND 20 DAYS POST-IMPLANT DUE TO UNKNOWN REASONS. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261291 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention