BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 3973538 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01762
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY OUR JAPAN AFFILIATE THAT DURING A TRANSFEMORAL TAVR PROCEDURE AV BLOCK AND ASYSTOLE WERE OBSERVED. BEFORE THE PROCEDURE THE PATIENT HAD SINUS RHYTHM AND OCCASIONALLY HAD PREMATURE ATRIAL CONTRACTIONS (PACS). DURING THE BALLOON AORTIC VALVULOPLASTY (BAV) RAPID VENTRICULAR PACING (RVP) WAS 200 BPM FOR 12 SECONDS. AFTER THE BAV SINUS RHYTHM WAS OBSERVED BUT THE BLOOD PRESSURE (BP) WAS SLOW TO RECOVER. THE BP INCREASED TO 104/46MMHG PRIOR TO THE IMPLANT OF THE VALVE. A 26MM SAPIEN XT VALVE, WITH 1ML LESS THAN THE NOMINAL VOLUME, WAS DEPLOYED. RVP WAS 200 BPM FOR 25 SECONDS. AFTER RVP WAS TURNED OFF, BRADYCARDIA, AV BLOCK, AND ASYSTOLE WERE OBSERVED IN SERIES. BACK UP PACING WAS INITIATED AT 70 BPM AND THE PATIENT¿S BP WAS 119/50MMHG. THE PROCEDURE WAS FINISHED AND AN EPICARDIAL PACING LEAD WAS LEFT IN THE PATIENT. A PERMANENT PACEMAKER WAS IMPLANTED 9 DAYS AFTER THE TAVR PROCEDURE. THE PATIENT HAS A HISTORY OF AORTIC STENOSIS, INTERSTITIAL PNEUMONIA, CHRONIC KIDNEY DISEASE, HYPERTENSION, HYPERLIPIDEMIA ILEUS, AND ANEMIA 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 BY EDWARDS IN A TECHNICAL SUMMARY, 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 REPORTED COMPLETE HEART BLOCK EVENT CANNOT BE CONFIRMED. HOWEVER, THE PROCEDURE ITSELF MAY HAVE CAUSED OR 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

    IT WAS REPORTED BY OUR (B)(4) AFFILIATE THAT DURING A TRANSFEMORAL TAVR PROCEDURE AV BLOCK AND ASYSTOLE WERE OBSERVED. BEFORE THE PROCEDURE THE PATIENT HAD SINUS RHYTHM AND OCCASIONALLY HAD PREMATURE ATRIAL CONTRACTIONS (PACS). DURING THE BALLOON AORTIC VALVULOPLASTY (BAV) RAPID VENTRICULAR PACING (RVP) WAS 200 BPM FOR 12 SECONDS. AFTER THE BAV SINUS RHYTHM WAS OBSERVED BUT THE BLOOD PRESSURE (BP) WAS SLOW TO RECOVER. THE BP INCREASED TO 104/46MMHG PRIOR TO THE IMPLANT OF THE VALVE. A 26MM SAPIEN XT VALVE, WITH 1ML LESS THAN THE NOMINAL VOLUME, WAS DEPLOYED. RVP WAS 200 BPM FOR 25 SECONDS. AFTER RVP WAS TURNED OFF, BRADYCARDIA, AV BLOCK, AND ASYSTOLE WERE OBSERVED IN SERIES. BACK UP PACING WAS INITIATED AT 70 BPM AND THE PATIENT¿S BP WAS 119/50MMHG. THE PROCEDURE WAS FINISHED AND AN EPICARDIAL PACING LEAD WAS LEFT IN THE PATIENT. A PERMANENT PACEMAKER WAS IMPLANTED 9 DAYS AFTER THE TAVR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450545 SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26J

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention