BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE / P140031

    MDR report key: 17497522 · Received August 10, 2023

    Report

    Report Number
    2015691-2023-15154
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    May 23, 2023
    Report Date
    October 31, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103194364
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED H6- INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR ADDITIONAL INFORMATION FROM RECEIVED FROM A PRODUCT EVALUATION. THE PRODUCT WAS NOT RETURNED; THEREFORE, A NO PRODUCT RETURN INVESTIGATION WAS COMPLETED. AS A DEVICE WAS NOT RETURNED, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL TESTING WERE NOT COMPLETED. NO IMAGERY WAS PROVIDED. REVIEW OF THE WORK ORDERS ABOVE DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. AS NO DEVICE WAS RETURNED AND THERE IS NO EVIDENCE TO SUPPORT A MANUFACTURING/DESIGN DEFECT POTENTIALLY CONTRIBUTED TO THE COMPLAINT, A MANUFACTURING MITIGATION REVIEW IS NOT REQUIRED. THE COMMANDER AND S3/ S3U IFU WAS REVIEWED. POTENTIAL ADVERSE EVENTS INCLUDE 'PARAVALVULAR OR TRANSVALVULAR LEAK' AND 'VALVE REGURGITATION'. 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 COMPLAINTS FOR CENTRAL REGURGITATION AND PARAVALVULAR LEAK WERE CONFIRMED BASED ON THE MEDICAL REPORT. A REVIEW OF THE DHR, LOT HISTORY, AND COMPLAINT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE 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 COMPLAINT EVENT. AS REPORTED, 'AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 1 YEAR, 9 MONTHS, AND 26 DAYS POST-IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 29 MM SAPIEN 3 VALVE WAS EXPLANTED. THE REASON FOR EXPLANT IS CENTRAL REGURGITATION AND PVL' TAVR IS POORLY SEATED.' PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE DUE TO A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. IN THIS CASE, THE INCIDENT VALVE (TAVR) WAS IMPROPERLY SEATED AS REPORTED. THE IMPROPER SEATED VALVE COULD HAVE DIFFICULTY TO SEAL THE PVL SKIRT AGAINST THE TARGET SITE (NATIVE ANNULUS), WHICH COULD RESULT IN PARAVALVULAR LEAK. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (IMPROPER SEATED VALVE) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE VALVE LEAFLET COAPTATION OR CLOSING WILL REQUIRE BLOOD FLOW BACK PRESSURE. IN THIS CASE, THE BLOOD FLOW BACK PRESSURE COULD BE DECREASED WITH THE PRESENCE OF PARAVALVULAR LEAK, WHICH LED TO SUBOPTIMAL LEAFLET COAPTATION RESULTING IN IN CENTRAL REGURGITATION AS REPORTED. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (PARAVALVULAR LEAK) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. SINCE NO DEVICE PROBLEM WAS IDENTIFIED AFFECTING DISTRIBUTED PRODUCT, NO PRA OR CAPAS ARE REQUIRED. SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING EVALUATION, A PRODUCT RISK ASSESSMENT ESCALATION IS NOT REQUIRED. SINCE NO EDWARDS DEFECTS WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 1 YEAR, 9 MONTHS, AND 26 DAYS POST-IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 29 MM SAPIEN 3 VALVE WAS EXPLANTED. THE REASON FOR EXPLANT IS CENTRAL REGURGITATION AND PVL. THE INTRAOPERATIVE (PRE-EXPLANT) TEE SHOWED LV EF 50-55%. MEDICAL RECORDS NOTED BIOPROSTHETIC AORTIC VALVE WITH MODERATE TO SEVERE AORTIC REGURGITATION. PARAVALVULAR LEAK BETWEEN THE NON AND RIGHT CORONARY CUSP. AV PEAK/MEAN GRADIENT 10/5MMHG. TAVR IS POORLY SEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279395 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE / P140031 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX 00690103194364

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention