BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4290126 · Received December 2, 2014

    Report

    Report Number
    2015691-2014-02844
    Event Type
    Injury
    Date Received
    December 2, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 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, IN ADDITION TO THE PROCEDURE ITSELF, IT IS POSSIBLE THE PATIENT¿S CARDIAC PATHOLOGY (E.G. CRITICAL AORTIC STENOSIS, PAROXYSMAL ATRIAL FIBRILLATION AND PRE-EXISTING JUNCTIONAL BRADYCARDIA) LIKELY CONTRIBUTED TO THIS 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 TERRITORY MANAGER, WHEN THE PATIENT¿S TEMPORARY PACEMAKER WAS TURNED DOWN, HER RATE WAS ONLY 20BPM. PRE-TAVR PROCEDURE, SHE WAS IN NORMAL SINUS RHYTHM. THE PATIENT RECEIVED A PERMANENT PACEMAKER ON POST OPERATIVE DAY (POD) 1 DUE TO ¿ASYSTOLE¿. MEDICAL RECORD REVIEW REVEALED A 26MM SAPIEN XT VALVE WAS SUCCESSFULLY DEPLOYED. POST DEPLOYMENT TEE AND ANGIOGRAM REVEALED EXCELLENT POSITIONING OF THE VALVE WITH TRACE AORTIC REGURGITATION. THE DEVICES WERE REMOVED AND THE FEMORAL CUTDOWN SITE WAS CLOSED. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION, WITH THE TEMPORARY PACEMAKER IN PLACE. THE PATIENT¿S TEMPORARY PACEMAKER RATE WAS SLOWED TO 20BPM AND NO RHYTHM WAS NOTED. THE PATIENT RECEIVED A PERMANENT PACEMAKER (PPM) DUE TO COMPLETE HEART BLOCK WITH ASYSTOLE IN THE SETTING OF ATRIAL FIBRILLATION. THE PATIENT¿S NATIVE ANNULUS MEASURED 15.9MM BY CT. THE VALVE AREA MEASURED 0.67CM2 BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE AORTIC VALVE WAS REPORTED TO BE CALCIFIED.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS TERRITORY MANAGER, WHEN THE PATIENT¿S TEMPORARY PACEMAKER WAS TURNED DOWN, HER RATE WAS ONLY 20BPM. PRE-TAVR PROCEDURE, SHE WAS IN NORMAL SINUS RHYTHM. THE PATIENT RECEIVED A PERMANENT PACEMAKER ON POST OPERATIVE DAY (POD) 3 DUE TO ¿ASYSTOLE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778949 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention