BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEAR VALVE

    MDR report key: 4201239 · Received October 27, 2014

    Report

    Report Number
    2015691-2014-02513
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 HEART BLOCK CANNOT BE CONFIRMED; HOWEVER, IN ADDITION TO THE PROCEDURE ITSELF, IT IS POSSIBLE THAT PATIENT FACTORS (CHF, ADVANCED AGE, SEVERELY CALCIFIED ANNULUS, ATRIAL FIBRILLATION) CONTRIBUTED TO THE EVENTS. 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

    POST TRANSAORTIC TAVR PROCEDURE, WHILE IN THE CVICU, THE PATIENT WENT INTO INTERMITTENT HEART BLOCK. DESPITE THE PLACEMENT OF A TEMPORARY PACEMAKER, CHEST COMPRESSIONS AND MULTIPLE SHOCKS THE PATIENT EXPIRED. PER THE MEDICAL RECORDS RECEIVED, THE 26MM SAPIEN VALVE WAS POSITIONED AND DEPLOYED WITHOUT DIFFICULTY. POST DEPLOYMENT TEE SHOWED TRIVIAL PVL AND MILD CAI. THERE WAS CONCERN THIS MIGHT BE A VALVE LEAFLET THAT WAS NOT FULLY MOBILE AS YET, IT MIGHT IMPROVE OVER TIME. THE SHEATH WAS REMOVED, THE ARTERIOTOMY WAS CLOSED AND PROTAMINE WAS ADMINISTERED. COMPLETE METICULOUS HEMOSTASIS WAS ACHIEVED AND LV FUNCTION WAS INDICATED TO BE GOOD WITH NO ISSUES. THE PATIENT WAS TRANSPORTED TO THE CVICU RECOVERY ROOM IN GOOD CONDITION. THE PATIENT¿S POST OPERATIVE CARE WAS COMPLICATED. WHILE IN THE CICU SHE WAS NOTED TO BE LETHARGIC AND IN SOME DEGREE OF RESPIRATORY DISTRESS. BLOODS GAS WAS CHECKED AND HER PH WAS 7.1 AND PC02 OF 90. HOWEVER, WITH INTUBATION AND INCREASED MINUTE VENTILATION, SHE DID NOT DO ANY BETTER AND SHE WENT INTO SHOCK. SHE WAS MARKEDLY HYPOTENSIVE. ECHO SUGGESTED GLOBAL CARDIAC DYSFUNCTION, BUT AS THIS WAS IMPROVED, THE EF INCREASED TO APPROX. 40% AND THERE WERE NO SEGMENTAL WALL MOTION ABNORMALITIES. THE SAPIEN VALVE WAS FUNCTIONING WELL. THE PATIENT WAS WITHOUT ADEQUATE UNDERLYING VENTRICULAR RATE WITH SOME INTERMITTENT BLOCK AND WAS REQUIRING INTERMITTENT CPR. SHE WAS TAKEN FOR PLACEMENT OF A TEMPORARY PACER, AS WELL AS CONSIDERATION OF A CORONARY ARTERIOGRAM. SHE HAD NO CLEARLY ISCHEMIC ECG CHANGES. THE PATIENT WAS QUIET ILL AND UNDERGOING CPR UPON ARRIVAL IN THE CATH LAB. A TEMPORARY PACER WAS PLACED IN THE RIGHT VENTRICLE. WITH CONTINUED CPR, SHE HAD MAXIMAL DOSES OF EPINEPHRINE, PHENYLEPHRINE, AND VASOPRESSIN STARTED. SHE WAS DEFIBRILLATED AT LEAST 3 TIMES FOR VENTRICULAR TACHYARRHYTHMIAS. HER ABDOMEN BEGAN TO BECOME A BIT MORE DISTENDED, AND THERE WAS CONCERN THAT SHE MIGHT HAVE ABDOMINAL BLEEDING. SHE HAD ALSO BEEN QUIET ACIDOTIC. CPR WAS CONTINUED AND RESUSCITATION WITH INTERMITTENT EPINEPHRINE BOLUSES AS WELL AS TRANSFUSION OF 6 UNITS OF BLOOD. AFTER 1 HOUR, SHE STILL HAD NO PERFUSING PULSE. AFTER DISCUSSION WITH ALL TEAM MEMBERS, RESUSCITATION WAS STOPPED AND THE PATENT WAS PRONOUNCED. AN AUTOPSY WILL NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681273 EDWARDS SAPIEN TRANSCATHETER HEAR VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death| O