BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3

    MDR report key: 10344940 · Received July 30, 2020

    Report

    Report Number
    2015691-2020-12849
    Event Type
    Death
    Date Received
    July 30, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 27, 2020
    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 · 0

    SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN EVENT SECTION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 5 </NOE> EVENTS OF MYOCARDIAL INFARCTION DEATH EVENTS FOR THE SAPIEN 3 FOR(B)(6)2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 5 EVENTS OF MYOCARDIAL INFARCTION FOR THE SAPIEN 3 VALVE IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0.4. 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 PERI-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 DEATH EVENT SUBMISSION FOR (B)(6) 2020 DATA EXTRACT FOR AORTIC DEATH FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 5 EVENTS OF MYOCARDIAL INFARCTION DEATH EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 70 TO 82. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 MALES AND 3 FEMALES. (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q4 2019 (OCTOBER 1 ¿ DECEMBER 31).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812352 EDWARDS SAPIEN 3 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death