BEUDAMED
    FDA Adverse Event Death Summary report: N

    THV VALVE UNKNOWN

    MDR report key: 7401216 · Received April 5, 2018

    Report

    Report Number
    2015691-2018-01264
    Event Type
    Death
    Date Received
    April 5, 2018
    Date of Event
    December 31, 2013
    Report Date
    March 13, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS TWO OF EIGHT MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NUMBERS: 2015691-2018-01272, 2015691-2018-01264, 2015691-2018-01265, 2015691-2018-01266, 2015691-2018-01267, 2015691-2018-01268, 2015691-2018-01271, 2015691-2018-01270.

    Additional Manufacturer Narrative · 1

    THE PMA NUMBER FOR THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE IS P110021 AND THE PMA NUMBER FOR THE EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE IS P130009. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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 FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO 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 CONTRIBUTE TO CORONARY OCCLUSION BY THE PROSTHETIC VALVE OR NATIVE VALVE LEAFLETS, INCLUDING A MINIMAL DISTANCE BETWEEN THE NATIVE ANNULUS AND THE CORONARY OSTIA, BULKY CALCIFICATION, LONG NATIVE LEAFLETS, OBLITERATED CORONARY SINUSES, 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. PROCEDURAL FACTORS SUCH AS TORN NATIVE LEAFLET DURING BAV, PLAQUE SHIFT, DEPLOYMENT OF THE BIOPROSTHETIC HEART VALVE TOO AORTIC AND SIGNIFICANT VALVE OVER SIZING COULD ALSO CONTRIBUTE TO THIS COMPLICATION. THE EDWARDS THV TRAINING 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. THE PHYSICIAN IS INSTRUCTED TO EVALUATE THIS RISK EARLY IN THE PATIENT SCREENING PROCESS IN ALL PATIENTS THE FOLLOWING FACTORS SHOULD BE CONSIDERED: DEGREE OF CALCIFICATION ON LEAFLETS, ANNULUS TO CORONARY OSTIA DISTANCE, LENGTH OF THE VALVE LEAFLET, WIDTH OF THE VALSALVA SINUSES, MOVEMENT OF THE LEAFLETS DURING BAV, PATENCY OF CORONARIES DURING BAV, AND EXPANDED HEIGHT OF THE INTENDED THV. THE TRAINING MANUALS ALSO PROVIDE THE FOLLOWING TIPS FOR DETECTING RISK FOR LEFT MAIN OCCLUSION: AORTOGRAM OR TEE PRIOR TO THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS; DURING PRE-DILATATION, NOTE BULKY CALCIFICATION ON VALVE MOVING TOWARDS OSTIUM ON LEFT MAIN; AND CONSIDER AORTOGRAM DURING VALVULOPLASTY TO ASSESS CORONARY FLOW. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE FOR THE LEFT MAIN CORONARY OBSTRUCTION COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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 BY OUR AFFILIATES IN (B)(4), PER THE ARTICLE "TRANSCATHETER AORTIC AND MITRAL VALVE-IN-VALVE IMPLANTATION FOR FAILED SURGICAL BIOPROSTHETIC VALVES AN 8-YEAR SINGLE-CENTER EXPERIENCE¿, A TOTAL OF 73 PATIENTS WITH AORTIC (42 PATIENTS) AND MITRAL (31 PATIENTS) BIOPROSTHETIC VALVE DYSFUNCTION UNDERWENT TRANSCATHETER VALVE IN VALVE IMPLANTATION BETWEEN APRIL 2007 AND DECEMBER 2013. EDWARDS BALLOON-EXPANDABLE TRANSCATHETER VALVES WERE USED AT A SINGLE CENTER. THE FIRST-IN-HUMAN AORTIC AND MITRAL VALVE IN VALVE IMPLANTATIONS WERE PERFORMED BY THE IMPLANTATION OF 23MM AND 26MM CRIBIER-EDWARDS EQUINE VALVES, RESPECTIVELY, USING A TRANSAPICAL APPROACH. IN ALL SUBSEQUENT CASES, BOVINE EDWARDS SAPIEN AND SAPIEN XT VALVES WERE IMPLANTED THROUGH EITHER A TRANSFEMORAL OR TRANSAPICAL APPROACH. TRANSAPICAL ACCESS WAS THE ONLY APPROACH THAT WAS USED FOR MITRAL VALVE IN VALVE IMPLANTATION. LEFT MAIN CORONARY OBSTRUCTION OCCURRED IN ONE PATIENT FOLLOWING IMPLANTATION OF A SAPIEN VALVE INTO A PRE-EXISTING SURGICAL AORTIC VALVE. DESPITE EMERGENCY CONVERSION TO OPEN-HEART AVR, THE PATIENT EXPIRED THE FOLLOWING DAY. REFERENCE: YE ET AL. TRANSCATHETER AORTIC AND MITRAL VALVE-IN-VALVE IMPLANTATION FOR FAILED SURGICAL BIOPROSTHETIC VALVES, AN 8-YEAR SINGLE-CENTER EXPERIENCE. JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8 NO. 13, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243210 THV VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES THV VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death