BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE.

    MDR report key: 10402731 · Received August 13, 2020

    Report

    Report Number
    2015691-2020-13067
    Event Type
    Death
    Date Received
    August 13, 2020
    Date of Event
    November 1, 2017
    Report Date
    July 22, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS TWO OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  PLEASE REFERENCE RELATED MANUFACTURER REPORT NO:  2015691-2020-13065.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS TWO OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM NOVEMBER 2017-JUNE 2018. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-NOV-2017) WAS USED AS THE OCCURRENCE DATE.   IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE:  P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE.   PLEASE REFERENCE ¿HAMANDI, MOHANAD, ET AL. "BIOPROSTHETIC VALVE FRACTURE DURING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT." BAYLOR UNIVERSITY MEDICAL CENTER PROCEEDINGS. TAYLOR & FRANCIS, 2020.¿   PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO THE CORONARY OSTIA. IN ADDITION, IT WARNS THAT CAUTION SHOULD BE EXERCISED IN IMPLANTING A BIOPROSTHESIS IN PATIENTS WITH CLINICALLY SIGNIFICANT CORONARY ARTERY DISEASE.  CORONARY OBSTRUCTION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G. PERCUTANEOUS CORONARY INTERVENTION (PCI)).  THERE ARE MULTIPLE PATIENT FACTORS THAT COULD PUT THE PATIENT AT RISK FOR CORONARY FLOW OBSTRUCTION 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  INVESTIGATION RESULTS SUGGEST/INDICATE THE CAUSE OF THE CORONARY OCCLUSION AND SUBSEQUENT DEATH IS UNKNOWN, HOWEVER MAY BE DUE TO PATIENT FACTORS NOT PROVIDED BY THE AUTHOR (E.G. LOW CORONARY HEIGHT, LONG NATIVE LEAFLETS, PRE-EXISTING CAD) AND/OR PROCEDURAL FACTORS NOT PROVIDED (E.G. VALVE DEPLOYED TOO AORTIC).   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

    AS REPORTED THROUGH ARTICLE "BIOPROSTHETIC VALVE FRACTURE DURING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT" REGARDING A SINGLE-CENTER STUDY OF 12 PATIENTS WHO UNDERWENT A BIOPROSTHETIC VALVE FRACTURING (BVF) VALVE IN VALVE (VIV) TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FROM NOVEMBER 2017-JUNE 2018 THE FOLLOWING EVENT WAS FOUND: -¿THERE WAS ONE INTRAOPERATIVE DEATH. PATIENT WAS ADMINISTERED PROTAMINE SULFATE AND SUBSEQUENTLY ENTERED A STATE OF PULSELESS ELECTRICAL ACTIVITY. CARDIOPULMONARY BYPASS WAS PERFORMED, AND CANNULATION OF THE CORONARY ARTERIES WAS ATTEMPTED. ANGIOGRAPHY SHOWED SIGNIFICANT OCCLUSIONS, AND SUBSEQUENT ATTEMPTS AT CANNULATION WERE AGAIN UNSUCCESSFUL. FOLLOWING THE OPERATION, CORONARY OCCLUSION WAS THE SUSPECTED CAUSE OF DEATH.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865904 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| R