BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 19986403 · Received August 14, 2024

    Report

    Report Number
    2015691-2024-06134
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    June 1, 2015
    Report Date
    August 15, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED TO REFERENCE A RELATED REPORTS. SECTIONS: G3, G6, H2, H11 HAVE BEEN UPDATED. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2024-06133, 2015691-2024-06132, 2015691-2024-06135, 2015691-2024-06137.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. REFERENCE: BIANCHINI, FRANCESCO, ET AL. "ANATOMICAL ANNULUS PREDICTORS OF NEW PERMANENT PACEMAKER IMPLANTATION RISK AFTER BALLOON-EXPANDABLE TRANS-CATHETER AORTIC VALVE IMPLANTATION." THE AMERICAN JOURNAL OF CARDIOLOGY (2024). THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM JUNE 2015 TO OCTOBER 2023. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-JUNE-2015) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; P140031 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM; P140031 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE SYSTEM. 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, AN ELLIPTICAL ANNULUS SHAPE, AND VALVE UNDER-SIZING. 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 PATIENTS 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 SUGGEST BASED ON THE LIMITED INFORMATION PROVIDED BY THE ARTICLE, A CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    AS REPORTED THROUGH REVIEW OF MEDICAL ARTICLE IN ITALY "ANATOMICAL ANNULUS PREDICTORS OF NEW PERMANENT PACEMAKER IMPLANTATION RISK AFTER BALLOON- EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION" , CORRESPONDING AUTHOR ENRICO ROMAGNOLI. THIS STUDY INCLUDED PATIENTS WHO UNDERWENT TAVI AND RECEIVED A NEW GENERATION BEVS (SAPIEN 3 AND SAPIEN 3 ULTRA, EDWARDS LIFESCIENCES) AT FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI FROM JUNE 2015 TO OCTOBER 2023. THE INCIDENCE AND PREDICTORS OF NEW PPI AT THE 30-DAY FOLLOW-UP CONSTITUTED THE PRIMARY END POINT OF THIS STUDY. THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: TABLE 4 PROCEDURAL COMPLICATIONS AND EARLY CLINICAL OUTCOMES: 2 PATIENTS PATIENT WITH AN UNKNOWN SAPIEN VALVE IMPLANTED HAD MODERATE OR ABOVE PVL AFTER THE VALVE IMPLANTATION AND DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992352 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention