BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4111050 · Received September 23, 2014

    Report

    Report Number
    2015691-2014-02215
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MIGRATION REQUIRING INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT. ACCORDING TO LITERATURE REVIEW, VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE TRANSCATHETER HEART VALVE (THV) OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE AORTIC WALL. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, AND INCORRECT BIOPROSTHETIC VALVE SIZING, CAN CONTRIBUTE TO VALVE MIGRATION. ADDITIONALLY, RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE LEFT VENTRICLE. THE EDWARDS THV PATIENT SCREENING MANUAL ADVISES THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE AND ROOT, TAKING INTO CONSIDERATION THE DEGREE AND DISTRIBUTION OF NATIVE LEAFLET CALCIFICATION. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT SIZING, ALIGNMENT AND POSITIONING OF THE DEVICE ARE EMPHASIZED AS KEY FACTORS TO THE PLACEMENT AND FIXATION OF THE DEVICE. PER THE INSTRUCTIONS FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIO-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. IN THIS CASE, THE CAUSE OF VALVE MIGRATION CANNOT BE CONFIRMED. THE PATIENT¿S NATIVE VALVE WAS REPORTED TO BE HEAVILY CALCIFIED. IT IS POSSIBLE THAT THIS HEAVY CALCIFICATION CONTRIBUTED TO THE VALVE MIGRATION. THERE APPEARED TO BE THROMBUS ON THE BIOPROSTHETIC VALVE WHICH LIKELY CAUSED THE THICKENED LEAFTLETS AND INCREASED VELOCITIES ACROSS THE VALVE. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT IMPLANT REGISTRY, A SECOND 26MM SAPIEN XT VALVE WAS IMPLANTED IN AN EXISTING 26MM SAPIEN XT VALVE 9 DAYS POST TAVR. MEDICAL RECORD REVIEW REVEALED THE TRANSFEMORAL TAVR PROCEDURE WAS INITIALLY UNCOMPLICATED. THE PATIENT WAS DOING WELL AND DISCHARGED 5 DAYS POST PROCEDURE. TWO DAYS POST DISCHARGE, THE PATIENT REPORTED SHORTNESS OF BREATH WHILE BENDING OVER AND HEAVINESS IN THE CHEST WITH EXERTION, IN THE MORNING AND THE EVENING. WHEN AN EXTRA DOSE OF LASIX DID NOT RESOLVE HER SYMPTOMS, SHE DECIDED TO GO TO THE HOSPITAL. THE PATIENT WAS FOUND TO BE HYPOXIC ON ROOM AIR WITH A SATURATION OF 88%. SHE WAS ADMITTED FOR ACUTE HYPOXEMIA AND POSSIBLE FLUID OVERLOAD. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) INDICATED THE BIOPROSTHETIC VALVE WAS IN THE LVOT, AND THE NATIVE VALVE WAS NOTED TO BE HEAVILY CALCIFIED. A COMBINATION OF PARAVALVULAR AND TRANSVALVULAR JETS WAS NOTED, RESULTING IN AT LEAST MODERATE AORTIC REGURGITATION. COMPARISON OF THE TEE RESULTS WITH THE POST-TAVR IMAGES REVEALED THE VALVE HAD MIGRATED INTO THE LVOT, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL) AND MILD TRANSVALVULAR AORTIC REGURGITATION. THE BIOPROSTHETIC VALVE ALSO APPEARED TO BE THICKENED WITH INCREASED VELOCITIES ACROSS THE VALVE, AND A SUGGESTION OF HYPERECHOIC MASSES IN THE LVOT AND THROMBUS OF THE VALVE. A SECOND 26MM SAPIEN XT VALVE WAS POSITIONED AND DEPLOYED APPROXIMATELY 4MM DISTAL TO THE FIRST VALVE IN ORDER TO ATTAIN EXCLUSION OF THE NATIVE LEAFLETS FROM THE ORIFICE. TEE AND AORTOGRAPHY REVEALED SUCCESSFUL DEPLOYMENT WITH NO SIGNIFICANT AORTIC INSUFFICIENCY. FOLLOWING THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO CT ICU IN STABLE CONDITION, BUT STILL INTUBATED. SHE WAS EXTUBATED WITHIN A SHORT PERIOD OF TIME AND HAD A SMOOTH POSTOPERATIVE COURSE. THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION ON POSTOPERATIVE DAY (POD) 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592234 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention