BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 10503443 · Received September 8, 2020

    Report

    Report Number
    2015691-2020-13472
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    September 16, 2019
    Report Date
    August 17, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-13476 AND MANUFACTURER REPORT NO: 2015691-2020-13478.

    Additional Manufacturer Narrative · 1

    THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED ¿ EDWARDS SAPIEN TRANSCATHETER HEART VALVE ¿ PMA P110021, EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE ¿ PMA P130009, OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ¿ PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), CENTRAL REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO CENTRAL REGURGITATION INCLUDING MALPOSITION OF THE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER INFLATION OF THE DEPLOYMENT BALLOON, POST DILATION OF THE IMPLANTED VALVE, AND SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. ALL OF THESE FACTORS HAVE THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED INTRAVALVULAR/CENTRAL REGURGITATION COULD NOT BE CONFIRMED BASED ON THE LIMITED INFORMATION AVAILABLE. IN ADDITION TO THE PROCEDURE ITSELF, PATIENT FACTORS NOT PROVIDED MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. REFERENCE FOR ARTICLE: DOMINICI, CARMELO; SALSANO, ANTONIO; NENNA, ANTONIO; SPADACCIO, CRISTIANO; BARBATO, RAFFAELE; MARISCALCO, GIOVANNI; SANTINI, FRANCESCO; BASHIR, MOHAMAD; EL-DEAN, ZEIN; CHELLO, MASSIMO JOURNAL OF CARDIOVASCULAR MEDICINE: MAY 2020 - VOLUME 21 - ISSUE 5 - P 383-390 DOI: 10.2459/JCM.0000000000000968 HTTPS://JOURNALS.LWW.COM/JCARDIOVASCULARMEDICINE/ABSTRACT/2020/05000/HIGHER_PREOPERATIVE_LEFT_ATRIAL_VOLUME_INDEX.6.ASPX . THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, ¿HIGHER PREOPERATIVE LEFT ATRIAL VOLUME INDEX PREDICTS LACK OF MITRAL REGURGITATION IMPROVEMENT AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT¿, 113 PATIENTS WITH PREOPERATIVE MODERATE TO SEVERE MITRAL REGURGITATION, UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURES FROM JANUARY 2010 TO DECEMBER 2017 . PREOPERATIVE AND POSTOPERATIVE ECHOCARDIOGRAPHY RESULTS WERE COMPARED IN TERMS OF MITRAL REGURGITATION AND OTHER COMMONLY MEASURED PARAMETERS. ALL TAVR PROCEDURES WERE PERFORMED VIA TRANSFEMORAL OR, IF NOT TECHNICALLY FEASIBLE, A TRANSAPICAL APPROACH USING THE MORE RECENTLY AVAILABLE VERSION OF EDWARDS SAPIEN VALVES THROUGHOUT THE STUDY. TAVR PROCEDURES WERE PERFORMED USING THE ¿MORE RECENTLY AVAILABLE VERSION OF THE SAPIEN VALVES¿. INTRAVALVULAR (CENTRAL) AORTIC REGURGITATION WAS REPORTED IN 6 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969379 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention