BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS UNKNOWN SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8362390 · Received February 22, 2019

    Report

    Report Number
    2015691-2019-00614
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED 1 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00610. THIS EVENT IS RELATED TO THE DISLOCATION/EMBOLIZATION. PLEASE REFERENCE RELATED 2 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00611. THIS EVENT IS RELATED TO THE STROKE. PLEASE REFERENCE RELATED 3 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00612. THIS EVENT IS RELATED TO THE MAJOR AND MINOR VASCULAR COMPLICATIONS. PLEASE REFERENCE RELATED 4 OF 5 MANUFACTURER REPORT NO: (B)(4).. THIS EVENT IS RELATED TO THE CONDUCTION DISORDERS. PLEASE REFERENCE RELATED 5 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00616. THIS EVENT IS RELATED TO THE VALVE IN VALVE PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THIS IS FOUR OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THIS EVENT IS RELATED TO THE CONDUCTION DISORDERS. REFERENCE ARTICLE: SCHERNER, MAXIMILIAN, NAVID MADERSHAHIAN, KATHRIN KUHR, STEPHAN ROSENKRANZ, ELISABETH STÖGER, PARWIS RAHMANIAN, YEONGHOON CHOI ET AL. "AORTIC VALVE REPLACEMENT AFTER PREVIOUS HEART SURGERY IN HIGH-RISK PATIENTS: TRANSAPICAL AORTIC VALVE IMPLANTATION VERSUS CONVENTIONAL AORTIC VALVE REPLACEMENT¿A RISK-ADJUSTED AND PROPENSITY SCORE-BASED ANALYSIS." THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 148, NO. 1 (2014): 90-97. 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 CLINICAL TECHNICAL SUMMARY 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE ARTICLE DID NOT HAVE DETAILS OF THE EVENTS. THESE EVENTS WERE LISTED AS 30 DAY OUTCOMES. THE CAUSE OF THE CONDUCTION DISORDERS IS UNKNOWN; HOWEVER, THE MECHANISMS DESCRIBED ABOVE MAY HAVE 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 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

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN GERMANY, THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿AORTIC VALVE REPLACEMENT AFTER PREVIOUS HEART SURGERY IN HIGH-RISK PATIENTS: TRANSAPICAL AORTIC VALVE IMPLANTATION VERSUS CONVENTIONAL AORTIC VALVE REPLACEMENT¿A RISK-ADJUSTED AND PROPENSITY SCORE-BASED ANALYSIS¿ CORRESPONDING AUTHOR DR. MAXIMILIAN SCHERNER ET AL. THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO EDWARDS DEVICES: IN THE GROUP OF PATIENTS WHO UNDERWENT TA-AVI AS A SECONDARY CARDIAC OPERATION (REDO TA-AVI) WITH AN EDWARDS SAPIEN VALVE, THE FOLLOWING 30-DAY OUTCOMES WERE OBSERVED: 1 PATIENT WAS CONVERTED TO CONVENTIONAL AVR DUE TO VALVE DISLOCATION/EMBOLIZATION AND EXPIRED. 1 PATIENT HAD A STROKE. 3 PATIENTS HAD BOTH MAJOR AND MINOR VASCULAR COMPLICATIONS. 1 PATIENT DEVELOPED A NEW LEFT BUNDLE BRANCH BLOCK AND 3 PATIENTS REQUIRED NEW PERMANENT PACEMAKER IMPLANTATION DUE TO NEW ATRIOVENTRICULAR BLOCK, THIRD DEGREE. 2 PATIENTS REQUIRED UNPLANNED VALVE-IN-VALVE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154374 EDWARDS UNKNOWN SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN SAPIEN TRANSCATHETER HEART VALVE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention