BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 18705070 · Received February 14, 2024

    Report

    Report Number
    2015691-2024-01002
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    July 1, 2021
    Report Date
    April 1, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2024-00989, 2015691-2024-01003 AND 2015691-2024-01024.

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (THV) PROCEDURE. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE LANDING ZONE, UNEVEN DISTRIBUTION OF CALCIUM ON THE LANDING ZONE, BULKY OR SEVERE CALCIFICATION, A LANDING ZONE WITH AN ELLIPTICAL SHAPE, AND VALVE UNDER OR OVERSIZING. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV (ALL MODELS). THE THV TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROPER IMAGING SCREENING REQUIREMENTS, INCLUDING THE USE OF GOOD QUALITY ECHOCARDIOGRAPHY AND/OR COMPUTED TOMOGRAPHY (CT) TO APPROPRIATELY MEASURE THE LANDING ZONE, ASSESS THE CONTENT AND DISTRIBUTION OF CALCIUM, AND OTHER PATIENT ANATOMICAL FACTORS. MULTIPLE IMAGING MODALITIES SHOULD BE CONSIDERED DURING VALVE SIZE SELECTION. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER THV ARE ALSO DISCUSSED. THE THV TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING PATIENT SCREENING AND PROCEDURAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES ARE ALSO INCLUDED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS ARE INCONCLUSIVE AS RELEVANT PATIENT AND PROCEDURAL FACTORS WERE NOT PROVIDED. HOWEVER, THE EVENT MAY BE RELATED TO THE MECHANISM DESCRIBED ABOVE. 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. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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. UEYAMA, HIROKI A., ET AL. "TRANSCATHETER PARAVALVULAR LEAK CLOSURE WITH COVERED STENT TRACT AND VASCULAR PLUG: TOOTSIE ROLL TECHNIQUE." JACC: CARDIOVASCULAR INTERVENTIONS (2024). H3 OTHER TEXT : VALVE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED, PER ARTICLE "TRANSCATHETER PARAVALVULAR LEAK CLOSURE WITH COVERED STENT TRACT AND VASCULAR PLUG", THIS SINGLE-CENTER RETROSPECTIVE STUDY INCLUDED ALL CONSECUTIVE PATIENTS WHO UNDERWENT THE NOVEL TOOTSIE ROLL TECHNIQUE FOR PVL CLOSURE BETWEEN JULY 2021 AND MAY 2023 AT THE EMORY UNIVERSITY HEALTHCARE SYSTEM. EIGHT PATIENTS WITH THV-RELATED PVL WERE TREATED USING THIS METHOD. ALL HAD TECHNICAL SUCCESS WITH IMMEDIATE ELIMINATION OF TARGET PVL, WITHOUT IN-HOSPITAL COMPLICATIONS. NONE HAD SIGNS OF POSTPROCEDURAL HEMOLYSIS. ALL PATIENTS WERE DISCHARGED ALIVE. DURING A TAVR PROCEDURE USING A 26MM SAPIEN 3 XT VALVE, PARAVALVULAR LEAK (PVL) WAS OBSERVED BETWEEN THE NON-CORONARY CUSP (NCC) AND LEFT HEART CATHETERIZATION (LCC), AND A TOOTSIE ROLL TECHNIQUE FOR PVL CLOSURE WAS SUCCESSFULLY PERFORMED. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431708 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention