BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 10555624 · Received September 18, 2020

    Report

    Report Number
    2015691-2020-13631
    Event Type
    Death
    Date Received
    September 18, 2020
    Date of Event
    July 1, 2011
    Report Date
    August 25, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2020-13624 AND 2015691-2020-13628. CITATION: KARADUMAN, BILGE DURAN, ET AL. "EVALUATION OF PROCEDURAL AND CLINICAL OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION: A SINGLE-CENTER EXPERIENCE." ANATOLIAN JOURNAL OF CARDIOLOGY 23.5 (2020): 288. 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 OVER SIZING, 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE EXACT CAUSE OF THE ANNULAR RUPTURE IS UNKNOWN BUT PATIENT FACTORS (SEVERE AORTIC STENOSIS) AND/OR PROCEDURAL FACTORS (DEVICE MANIPULATION) MAY HAVE CONTRIBUTED TO THE EVENT. 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 THE FAILURE MODE 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 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

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE: ¿EVALUATION OF PROCEDURAL AND CLINICAL OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION: A SINGLE-CENTER EXPERIENCE". CORRESPONDING AUTHOR DR. ENGIN BOZKURT. THE FOLLOWING EVENTS WERE IDENTIFIED: THIS RETROSPECTIVE, SINGLE-CENTER ANALYSIS INCLUDED 556 CONSECUTIVE PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS (AS) WHO UNDERWENT TAVI BETWEEN JULY 2011 AND DECEMBER 2019. THE FOLLOWING FOUR TYPES OF AORTIC VALVES WERE AVAILABLE: EDWARDS SAPIEN XT, SAPIEN 3 VALVE (EDWARDS LIFESCIENCES, IRVINE, CALIFORNIA), LOTUS¿ VALVE SYSTEM (BOSTON SCIENTIFIC, MA, USA), AND ACURATE NEO¿ (BOSTON SCIENTIFIC). THE EDWARDS SAPIEN XT WAS USED IN 480 PATIENTS AND THE EDWARDS SAPIEN 3 IN 46 PATIENTS. ONE (1) PATIENT HAD AN ANNULAR RUPTURE DURING VALVE IMPLANTATION WITH A 23MM SAPIEN XT THV LEADING TO DEATH. WHEN THIS PATIENT WAS EXAMINED IN DETAIL, THE MOST LOGICAL EXPLANATION WAS THAT THEY HAD SEVERE AS WITH AN AORTIC VELOCITY OF 7 CM/SN AND A MEAN GRADIENT OF 147 MM HG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019005 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 Death