BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3796547 · Received May 7, 2014

    Report

    Report Number
    2015691-2014-01047
    Event Type
    Death
    Date Received
    May 7, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM INJURIES (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, 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 EXACT CAUSE OF THE COMPLETE HEART BLOCK IS UNKNOWN. HOWEVER, THE PROCEDURE ITSELF, IN COMBINATION WITH THE PATIENT¿S CO-MORBIDITIES (CAD, CABG, CHF, HTN) 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO. 2015691-2014-01045.

    Description of Event or Problem · 1

    THE PATIENT PASSED AWAY THREE DAYS POST TRANSAPICAL TAVR PROCEDURE, WITH THE REPORTED CAUSE OF DEATH BEING COMPLETE HEART BLOCK. POST SUCCESSFUL VALVE IMPLANT, THE PATIENT WAS TRANSFERRED TO THE ICU WITH VENT SUPPORT AS WELL AS PRESSOR SUPPORT. LATER THAT DAY, THE PATIENT WAS DIAGNOSED WITH AN ACUTE ISCHEMIC STROKE. SHE WAS TREATED MEDICALLY; HOWEVER WAS NOT A CANDIDATE FOR TPA BECAUSE OF THE RECENT TAVR. OVER THE COURSE OF THREE DAYS, THE PATIENT BECAME SEPTIC. POD 3, CODE BLUE WAS CALLED SECONDARY TO COMPLETE HEART BLOCK WHICH THEN PROGRESSED TO ASYSTOLE. ACLS PROTOCOL WAS FOLLOWED. THE PATIENT HAD 2 EPISODES OF RETURN OF SPONTANEOUS CIRCULATION AND THE CODE LASTED 15 MINUTES. THE PATIENT'S FAMILY WAS PRESENT AT THIS TIME. THE PHYSICIANS DISCUSSED THE PATIENT¿S CONDITION WITH THE FAMILY AND ALL WERE IN AGREEMENT WITH TERMINATION OF THE CODE. ULTIMATELY THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274062 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death