BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 17182952 · Received June 22, 2023

    Report

    Report Number
    2015691-2023-14131
    Event Type
    Injury
    Date Received
    June 22, 2023
    Report Date
    August 11, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2023-14133 AND 2015691-2023-14129.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. ISOGAI, TOSHIAKI, ET AL. "ONE-YEAR CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SAPIEN 3 ULTRA VERSUS SAPIEN 3." CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 101.2 (2023): 417-430. H3 OTHER TEXT : VALVE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6; DEVICE CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION. THE SAPIEN 3 VALVE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING, AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. THE FOLLOWING INSTRUCTIONS FOR USE (IFU) WERE REVIEWED: COMMANDER DS WITH SAPIEN 3. BASED ON THIS REVIEW, NO IFU/TRAINING DEFICIENCIES WERE IDENTIFIED. 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 THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINT FOR POST-IMPLANTATION- CENTRAL REGURGITATION WAS UNABLE TO BE CONFIRMED WITHOUT PROVIDED MEDICAL RECORDS OR IMAGERY. DUE TO UNAVAILABILITY OF VALVE SERIAL NUMBER, DHR REVIEW WAS UNABLE TO BE PERFORMED TO DETERMINE IF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION 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. PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (THV) PROCEDURE. CENTRAL REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO SEVERAL ISSUES INCLUDING PATIENT-RELATED FACTORS, STRUCTURAL VALVE DETERIORATION (E.G. CALCIFICATION, LEAFLET THICKENING), AND/OR NONSTRUCTURAL DYSFUNCTION (FIBROSIS, PANNUS FORMATION). AS REPORTED, "PATIENT WITH HISTORY OF MULTIPLE OPEN-HEART SURGERIES FOR TRUNCUS ARTERIOSUS UNDERWENT SURGICAL AV REPLACEMENT AND AORTIC ROOT REPLACEMENT WITH A COMPOSITE GRAFT FOR SEVERE PROSTHETIC AV REGURGITATION ON POST-TAVR DAY #274". IN THIS CASE, LIMITED PATIENT INFORMATION WAS PROVIDED, A CONCLUSIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED BY THE ARTICLE, "ONE-YEAR CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SAPIEN 3 ULTRA VERSUS SAPIEN 3", PATIENTS WHO UNDERWENT TRANSFEMORAL-TRANSCATHETER AORTIC VALVE REPLACEMENT WITH S3U OR S3 (20/23/26 MM) IN 2018-2020, OUTCOMES OF 1-YEAR CLINICAL EVENTS AND ECHOCARDIOGRAPHIC PARAMETERS WERE COMPARED BETWEEN S3U AND S3. APPROXIMATELY 9 MONTHS POST-TAVR PROCEDURE USING A SAPIEN 3 VALVE, ONE PATIENT WITH A HISTORY OF MULTIPLE OPEN-HEART SURGERIES FOR TRUNCUS ARTERIOSUS UNDERWENT SURGICAL AORTIC VALVE (AV) REPLACEMENT AND AORTIC ROOT REPLACEMENT WITH A COMPOSITE GRAFT FOR SEVERE PROSTHETIC AV REGURGITATION. THE PATIENT REQUIRED AORTIC VALVE (AV) RE-INTERVENTION WITHIN 1 YEAR AFTER S3 TAVR. THE EXACT DATE OF THE IMPLANT AND SPECIFIC PATIENT DEMOGRAPHICS WERE NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69100 SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention