BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 11979107 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03467
    Event Type
    Death
    Date Received
    June 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006. THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 7 EVENTS OF MYOCARDIAL INFARCTION DEATH EVENTS FOR THE SAPIEN 3 ULTRA IN THE AORTIC POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 0.86. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), THROMBUS FORMATION, PLAQUE DISLODGEMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION (MI) ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TAVR PROCEDURE. THE IFU CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO THE CORONARY OSTIA. IN ADDITION, CAUTION SHOULD BE EXERCISED WHEN IMPLANTING A BIOPROSTHESIS IN PATIENTS WITH CLINICALLY SIGNIFICANT CORONARY ARTERY DISEASE. MI RELATED TO THE TAVR PROCEDURE AND THE VALVE IMPLANT WILL MANIFEST INTRA-PROCEDURALLY OR IN THE IMMEDIATE POST-OPERATIVE PERIOD AND IS TYPICALLY DUE TO A COMBINATION OF PATIENT AND/OR PROCEDURAL FACTORS. AS DEFINED IN THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) PUBLICATION ON TAVR COMPLICATIONS, THE PER--PROCEDURAL INTERVAL IS INCLUSIVE OF ALL EVENTS THAT BEGIN WITHIN 72 HRS. OF THE INDEX PROCEDURE. MI'S THAT OCCUR AFTER THE PERI-PROCEDURAL PERIOD (>72 HRS.) ARE TYPICALLY RELATED TO THE PATIENT'S UNDERLYING CORONARY DISEASE. THERE ARE MULTIPLE PATIENT FACTORS THAT COULD PUT THE PATIENT AT RISK FOR MI DURING THE TAVR PROCEDURE, INCLUDING SIGNIFICANT UNDERLYING CORONARY ARTERY DISEASE, AND BULKY CALCIFICATION OF THE NATIVE LEAFLETS AND ROOT. DISPLACEMENT OF CALCIUM DEPOSITS WITH EMBOLIZATION OF DEBRIS INTO ONE OF THE ARTERIES, OR AORTIC DISSECTION WITH CONTINUITY OF THE RUPTURE INTO THE INTIMA OF ONE OF THE CORONARY OSTIA, CAN RESULT IN THIS COMPLICATION. THE EDWARDS THV MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE 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.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 1 2021 DATA EXTRACT FOR AORTIC DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 7 MYOCARDIAL INFARCTION DEATH EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 71 - 80 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES AND 5 MALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874255 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA VALVE UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death