BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 7985607 · Received October 19, 2018

    Report

    Report Number
    2015691-2018-04299
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    August 1, 2013
    Report Date
    September 25, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN XT AND SAPIEN 3: P130009, AND P140031 REFERENCE MFG. REPORTS: 2015691-2018-04304, 2015691-2018-04305, 2015691-2018-04309, 2015691-2018-04312, AND 2015691-2018-04313.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, AND SAPIEN XT: P100041, AND P130009. PER THE INSTRUCTIONS FOR USE, 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 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 IS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONFIRM THE CAUSE OF THE REPORTED EVENTS. HOWEVER, THE AV BLOCK WERE LIKELY RELATED TO THE MECHANISM DESCRIBED ABOVE. IN ADDITION, OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN. AS PER AUTHOR, IT WAS PROVEN THAT THE TAVI IS A SAFE AND EFFICIENT METHOD OF TREATING SEVERE AORTIC VALVE STENOSIS IN SELECTED PATIENT POPULATION. ONLY PERSISTING PERI-PROCEDURAL AND EARLY-ONSET COMPLETE HEART BLOCK WERE PERMANENT AND RESULTED IN PATIENTS¿ PACEMAKER DEPENDENCY. CLOSE MONITORING OF PATIENTS WITH KNOWN RISK FACTORS OF POST PROCEDURAL PACEMAKER REQUIREMENT IS WARRANT. 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: BACIK, P. (2018). WHO NEEDS A PERMANENT PACEMAKER AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION? BRATISL MEDICAL JOURNAL, 560-565.

    Description of Event or Problem · 1

    AS REPORTED THROUGH OUR (B)(6) AFFILIATE PER A LITERATURE ARTICLE: ¿WHO NEEDS A PERMANENT PACEMAKER AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION?¿ BETWEEN AUGUST 2013 AND MARCH 2017, 116 SYMPTOMATIC PATIENTS WITH SEVERE AORTIC STENOSIS UNDERWENT TAVI WITH A SAPIEN VALVE (SAPIEN XT WAS IMPLANTED IN 11 PATIENTS AND IN MAJORITY OF PATIENTS RECEIVED A SAPIEN 3 VALVE), (N = 105). PER ARTICLE, A TOTAL OF 16 PATIENTS REQUIRED PERMANENT PACEMAKER IMPLANTATION. THIS REPORT REPRESENTS THE REPORTED SEVEN (7) PATIENTS WITH COMPLETE AV BLOCK (INTERMITTENT OR PERSISTENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825885 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention