BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN VALVE UNKNOWN

    MDR report key: 8011952 · Received October 28, 2018

    Report

    Report Number
    2015691-2018-04417
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    January 1, 2011
    Report Date
    October 2, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM 2011 TO 2017. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-JAN 2011) WAS USED AS THE OCCURRENCE DATE. IT IS UNKNOWN IF A SAPIEN, SAPIEN XT OR SAPIEN 3 VALVE WAS IMPLANTED. THE PMA NUMBERS ARE P110021 FOR SAPIEN, P130009 FOR SAPIEN XT AND P100041 FOR SAPIEN 3. 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 TS ¿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 THESE ADVERSE EVENTS. THE CAUSE FOR THE PPM IMPLANTATIONS COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED BY THE AUTHORS. HOWEVER, IT IS POSSIBLE THAT THE REPORTED EVENTS WERE CAUSED BY THE MECHANISM EXPLAINED IN THE TECHNICAL SUMMARY MENTIONED 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.

    Description of Event or Problem · 1

    PER THE LITERATURE ARTICLE ¿IMPACT OF RIGHT VENTRICULAR PACING IN PATIENTS WHO UNDERWENT IMPLANTATION OF PERMANENT PACEMAKER AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION¿, A SINGLE CENTER RETROSPECTIVE STUDY OF PATIENT¿S WHO UNDERWENT TAVI BETWEEN 2011 AND 2017 WAS PERFORMED. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE THE IMPACT OF PERMANENT PACEMAKER (PPM) IMPLANT ON PATIENT OUTCOMES. OF THE 297 PATIENTS WHO HAD A SAPIEN VALVE IMPLANTED, 30 PATIENTS RECEIVED A PERMANENT PACEMAKER POST TAVI. THE PATIENTS REQUIRING PPM WERE MORE LIKELY TO HAVE PREVIOUS ATRIOVENTRICULAR DEFECTS AND RIGHT BUNDLE BRANCH BLOCK. REFERENCE: NADEEM, FAHD, ET AL. "IMPACT OF RIGHT VENTRICULAR PACING IN PATIENTS WHO UNDERWENT IMPLANTATION OF PERMANENT PACEMAKER AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION." THE AMERICAN JOURNAL OF CARDIOLOGY (2018).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851461 SAPIEN VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention