BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8404610 · Received March 8, 2019

    Report

    Report Number
    2015691-2019-00800
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 15, 2012
    Report Date
    February 14, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031. 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 AND 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, THE CAUSE OF THE CONDUCTION DISORDER IS LIKELY RELATED TO THE MECHANISM DESCRIBED ABOVE. OTHER POTENTIAL CONTRIBUTING FACTORS WERE NOT PROVIDED IN THE ARTICLE. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE 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 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. BIBLIOGRAPHY: MOHAMMED A. AL-HIJJI, M. C. (2019). LEFT VENTRICULAR REMODELING AND FUNCTION AFTER TRANSAPICAL VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT. CATHETERIZATION, CARDIOVASCULAR INTERVENTION, 1-7. REFERENCE MFG. REPORT NUMBERS: 2015691-2019-00788 AND 2015691-2019-00799.

    Description of Event or Problem · 1

    A SINGLE-CENTER RETROSPECTIVE STUDY OF ALL TAVR PERFORMED FROM FEBRUARY 2012 TO JUNE 2016 WAS PUBLISHED IN THE JOURNAL ARTICLE ¿LEFT VENTRICULAR REMODELING AND FUNCTION AFTER TRANSAPICAL VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT". THREE HUNDRED AND FIFTY-NINE PATIENTS UNDERWENT BALLOON-EXPANDABLE TAVR USING SAPIEN VALVES WERE INCLUDED. THESE CASES WERE BOTH TRANSAPICAL AND TRANSFEMORAL. ONE HUNDRED AND FIFTEEN PATIENTS WHO UNDERWENT TA TAVR (TA GROUP) WERE COMPARED TO 115 PROPENSITY MATCHED PATIENTS WHO UNDERGONE TF TAVR (TF GROUP). THIS REPORT IS FOR 5 PATIENTS REQUIRED A PERMANENT PACEMAKER (PPM) [TA] AND 9 PATIENTS REQUIRED A PPM [TA].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197565 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention