BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8378661 · Received February 28, 2019

    Report

    Report Number
    2015691-2019-00676
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    January 1, 2013
    Report Date
    February 4, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. BRAND NAME, MODEL #: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE LISTED BELOW: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE WITH COMMANDER DELIVERY SYSTEM (TF INDICATION). PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (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 WRITTEN BY EDWARDS LIFESCIENCES ¿CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS-CONDUCTION DISTURBANCES/ HEART BLOCK¿, 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  INVESTIGATION RESULTS ARE INCONCLUSIVE, IT MAY BE RELATED TO THE MECHANISM DESCRIBED ABOVE.   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 AT THIS TIME. ARTICLE REFERENCE: MAENO Y, ABRAMOWITZ Y, ISRAR S, YOON SH, KUBO S, NOMURA T, MIYASAKA M, KAWAMORI H, KAZUNO Y, TAKAHASHI N, CHAKRAVARTY T, NAKAMURA M, SHARMA RP, JILAIHAWI H, MAKKAR RR. PROGNOSTIC IMPACT OF PERMANENT PACEMAKER IMPLANTATION IN PATIENTS WITH LOW LEFT VENTRICULAR EJECTION FRACTION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. J INVASIVE CARDIOL. 2019 FEB; 31 (2): E15-E22. PUBMED PMID: 30700626.

    Description of Event or Problem · 1

    AS REPORTED THROUGH ARTICLE, ¿PROGNOSTIC IMPACT OF PERMANENT PACEMAKER IMPLANTATION IN PATIENTS WITH LOW LEFT VENTRICULAR EJECTION FRACTION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT¿, 68 PATIENTS THAT HAD A BALLOON-EXPANDABLE DEVICE (EDWARDS SAPIEN/SAPIEN XT/SAPIEN 3) IMPLANTED REQUIRED A NEW PERMANENT PACEMAKER (PPM) BETWEEN JANUARY 2013 AND DECEMBER 2015, A TOTAL OF 659 PATIENTS WITH SEVERE, SYMPTOMATIC AS UNDERWENT TAVR WITH PRE-PROCEDURAL CONTRAST CARDIAC COMPUTED TOMOGRAPHY (CT) AT OUR INSTITUTION. SEVERE AS WAS DEFINED BY AORTIC VALVE AREA <1.0 CM2, MEAN AORTIC VALVE GRADIENT OF 40 MM HG, OR A PEAK AORTIC JET VELOCITY OF 4.0 M/S. ALL PATIENTS HAD NEW YORK HEART ASSOCIATION CLASS II TO IV SYMPTOMS.  IMPLANTED VALVES INCLUDED EDWARDS SAPIEN, SAPIEN XT, AND SAPIEN 3 (EDWARDS LIFESCIENCES), AS WELL AS COREVALVE AND EVOLUTR (MEDTRONIC). FROM JANUARY 2013 TO DECEMBER 2015, A TOTAL OF 104 PATIENTS (15.8%) REQUIRED NEW PPI AFTER TAVR IN OUR INSTITUTION. THE INDICATION FOR NEW PPI WAS HIGH-GRADE ATRIOVENTRICULAR BLOCK IN 81 PATIENTS (77.9%). THE REMAINING PATIENTS HAD SICK SINUS SYNDROME (N = 12) OR SEVERE SYMPTOMATIC BRADYCARDIA WITH LESSER DEGREES OF CONDUCTION DISTURBANCES (N = 11). OF THOSE PATIENTS NEEDING PPI, A TOTAL OF 13 WERE REQUIRED TO HAVE PERMANENT SINGLE-CHAMBER PACING (12.5%). 68 PATIENTS THAT HAD A BALLOON-EXPANDABLE DEVICE (EDWARDS SAPIEN/SAPIEN XT/SAPIEN 3) REQUIRED A NEW PERMANENT PACEMAKER (PPM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172923 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention