BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 3843304 · Received June 2, 2014

    Report

    Report Number
    2015691-2014-01272
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CENTRAL REGURGITATION IS POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO CENTRAL VALVE REGURGITATION INCLUDING MALPOSITION OF THE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER INFLATION OF THE DEPLOYMENT BALLOON, POST DILATION OF THE IMPLANTED VALVE, AND SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. ALL OF THESE FACTORS HAVE THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. THE THV TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM INJURIES (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY FOR WRITTEN BY EDWARDS LIFESCIENCES, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AVR, WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND/OR SUTURE PLACEMENT IN THE PROXIMITY OF THE AV NODE OR THE BUNDLES, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THERE WAS NO REPORT OF CENTRAL REGURGITATION POST VALVE DEPLOYMENT. IT WAS REPORTED THAT AFTER POST DILATION, THE CENTRAL REGURGITATION AND COMPLETE HEART BLOCK OCCURRED. IT WAS PERCEIVED THAT THE VOLUME AND POSITION OF THE BALLOON DURING POST DILATION CAUSED THE LEAFLETS TO FLARE OUT, INDUCING MILD TO MODERATE CENTRAL AORTIC INSUFFICIENCY. WHILE THE EXACT CAUSE OF THE CHB CANNOT BE CONFIRMED, IT IS LIKELY THAT THE PROCEDURE ITSELF, IN ADDITION TO PATIENT FACTORS (CAD, CHF, AND AGE (B)(6)) AND TOO VENTRICULAR PLACEMENT OF THE VALVE CONTRIBUTED 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AFTER POST DILATION OF A SAPIEN VALVE, THERE WAS CENTRAL AI AND COMPLETE HEART BLOCK (CHB), REQUIRING DEPLOYMENT OF A SECOND VALVE AND A PERMANENT PACEMAKER. INITIALLY, NO BAV WAS PERFORMED. THE FIRST VALVE WAS POSITIONED 50/50 AND LANDED 40/60 AORTIC/VENTRICULAR. THERE WAS MILD PARAVALVULAR LEAK AND POST DILATION WAS PERFORMED WITH A 26 MM BAV. THE BALLOON WAS CENTERED TOO AORTIC, AND SUBSEQUENTLY THERE WAS MILD TO MODERATE CENTRAL AI. IN ADDITION, THE PATIENT WENT INTO CHB AT THIS TIME. A SECOND VALVE WAS PLACED IN LINE WITH THE FIRST VALVE AND LANDED 70/30 A/V. TRACE PVL AND NO CENTRAL AI WAS NOTED VIA TEE AND AORTOGRAM POST DEPLOYMENT. THE DELIVERY SYSTEM AND SHEATH WERE REMOVED WITHOUT ISSUE. THE APEX WAS CLOSED IN STANDARD SURGICAL FASHION. POST PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED WITHOUT ISSUE. THE PATIENT WAS EXTUBATED AND STABLE UPON TRANSFER TO THE ICU. THE PERCEIVED CAUSE OF THE CENTRAL AI WAS DURING POST DILATION OF THE FIRST VALVE, THE VOLUME AND POSITION OF THE BALLOON CAUSED THE LEAFLETS TO FLARE OUT, INDUCING MILD TO MODERATE CENTRAL AORTIC INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321408 EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 85 Required Intervention