BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3

    MDR report key: 10345036 · Received July 30, 2020

    Report

    Report Number
    2015691-2020-12851
    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 B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 4 </NOE> EVENTS OF ANNULAR DISSECTION DEATH EVENTS FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 4 EVENTS OF ANNULAR DISSECTION FOR THE SAPIEN 3 VALVE IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM, OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA, OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVERSIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. 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 4 EVENTS OF ANNULAR DISSECTION DEATH EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 80 TO 93. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 MALES AND 2 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
    810664 EDWARDS SAPIEN 3 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death