BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9428723 · Received December 6, 2019

    Report

    Report Number
    2015691-2019-04506
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    March 1, 2014
    Report Date
    November 11, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2019-04505, 2015691-2019-04507, 2015691-2019-04508. SUPPLEMENTAL TO REPORTED RELATED REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THIS REPORT IS FOR THE 5 PATIENTS REQUIRED A NEW PACEMAKER. THE DATE OF THE EVENTS IS UNKNOWN. ACCORDING TO THE ARTICLE THE DATE RANGE FOR THIS EVENT(S) IS FROM MARCH 2014 AND MAY 2018 USING AN EDWARDS SAPIEN (XT AND 3). FOR THIS REASON, THE FIRST DAY OF THE RANGE WAS USED AS THE OCCURRENCE DATE. THIS REPORT REPRESENTS THE 5 PATIENTS REPORTED TO HAVE REQUIRED A NEW PACEMAKER POST PROCEDURE. THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE LISTED BELOW. 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. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. IN THIS CASE, REPORTING AND CAPTURE ARE BEING DONE CONSERVATIVELY. NO ADDITIONAL PATIENT OR PROCEDURAL FACTORS WERE PROVIDED THAT COULD HELP DETERMINE A ROOT CAUSE. IT IS POSSIBLE THAT A CONDUCTION SYSTEM DISTURBANCE WAS 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. ARTICLE REFERENCE: NIELSEN NE, BARANOWSKA J, BRAMLAGE P, BARANOWSKI J. MINIMIZING THE RISK FOR LEFT VENTRICULAR RUPTURE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION BY REDUCING THE PRESENCE OF STIFF GUIDEWIRES IN THE VENTRICLE. INTERACT CARDIOVASC THORAC SURG. 2019 SEP 1;29(3):365-370. DOI: 10.1093/ICVTS/IVZ107. PUBMED PMID: 31135035.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE REVIEW OF THE MEDICAL ARTICLE: " MINIMIZING THE RISK FOR LEFT VENTRICULAR RUPTURE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION BY REDUCING THE PRESENCE OF STIFF GUIDEWIRES IN THE VENTRICLE". CORRESPONDING AUTHOR JACEK BARANOWSKI, 316 CONSECUTIVE PATIENTS WHO UNDERWENT TAVI AT A SINGLE INTERNATIONAL CENTER BETWEEN MARCH 2014 AND MAY 2018 USING AN EDWARDS SAPIEN (XT AND 3) TRANSCATHETER HEART VALVE WERE INCLUDED IN THIS RETROSPECTIVE OBSERVATIONAL STUDY. PROCEDURAL CHARACTERISTICS AND OUTCOME DATA WERE RECORDED ACCORDING TO VALVE ACADEMIC RESEARCH CONSORTIUM-2 CRITERIA AT 30 DAYS. PROCEDURAL SUCCESS WAS ACHIEVED IN ALL PATIENTS (100%). THE FOLLOWING EVENTS WERE IDENTIFIED DURING THE STUDY PERIOD: 1 PATIENT HAD A PERICARDIAL EFFUSION DUE TO AN ANNULAR RUPTURE. 5 PATIENTS REQUIRED A NEW PACEMAKER. 3 PATIENTS SUFFERED A STROKE DURING THE 30-DAY OUTCOME PERIOD. 6 PATIENTS EXPERIENCED VASCULAR COMPLICATIONS, FOUR OF WHICH WERE CONSIDERED MAJOR VASCULAR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225519 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other