BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3052989 · Received April 11, 2013

    Report

    Report Number
    2015691-2013-19792
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED SAPIEN VALVE WAS RETURNED TO EDWARDS FOR EVALUATION WITH THE SECOND DEPLOYED VALVE STILL INSIDE. THE FIRST SAPIEN VALVE APPEARED UNDER-EXPANDED, AS INDICATED BY THE BUNCHING OF THE SKIRT. THE ORIGINAL LEAFLET CONDITIONS AND THE FUNCTIONALITY OF THE FIRST VALVE COULD NOT BE EVALUATED AS THE LEAFLETS HAD BEEN PRESSED AGAINST THE FRAME BY THE DEPLOYMENT OF A SECOND VALVE. THE LEAFLETS OF THE SECOND VALVE WERE SLIGHTLY STIFF, MOST LIKELY DUE TO BEING STORED IN PRESERVING SOLUTION. THE FRAME WAS OBSERVED TO BE NON-CIRCULAR, WHICH MIGHT HAVE BEEN DUE TO DEPLOYMENT FACTORS AND/OR THE EXPLANT PROCEDURE. THE OUTER DIAMETER (OD) OF THE RETURNED VALVE WAS MEASURED AND INDICATED AN UNEVEN AND UNDER DEPLOYMENT OF THE VALVE. HOWEVER, THE INITIAL VALVE OD AFTER IT WAS DEPLOYED IN THE PATIENT COULD NOT BE DETERMINED AS THE EXPLANT PROCEDURE COULD HAVE AFFECTED THE VALVE OD. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINTS. ALL OF THE VALVES IN THE AFFECTED WORK ORDER PASSED THE LEAFLET COAPTATION TEST. PER THE INSTRUCTIONS FOR USE, ARRHYTHMIAS/CONDUCTION SYSTEM INJURIES (DEFECTS) ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. DAMAGE TO THE MYOCARDIUM AND ITS CONDUCTION SYSTEM CAUSES ACQUIRED HEART BLOCK AND CAN RESULT IN HEART BLOCK DURING OR AFTER THE PROCEDURE. THIS TYPICALLY OCCURS IN PATIENTS WITH UNDERLYING CARDIAC DISEASE AND/OR CONDUCTION ABNORMALITIES. ACCORDING TO LITERATURE REVIEW AND THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE PROCEDURE. OTHER FACTORS THAT COULD CONTRIBUTE TO THE ONSET OF CONDUCTION DEFECTS INCLUDE UNDERLYING HEART DISEASE, ELECTROLYTE DISTURBANCES, AND CERTAIN MEDICATIONS (I.E. BETA-BLOCKERS, CALCIUM CHANNEL BLOCKERS). IN ADDITION, PER THE IFU, DEVICE MALPOSITION REQUIRING INTERVENTION, VALVE REGURGITATION, AND DEVICE MIGRATION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. 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 AND RETROGRADE FORCES DURING DIASTOLE. THE LITERATURE REPORTS THAT LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, AND INCORRECT BIOPROSTHETIC VALVE SIZING CAN CONTRIBUTE TO VALVE MIGRATION. FURTHERMORE, THE LITERATURE REPORTS THAT RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE LEFT VENTRICLE. THE 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 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. IN THIS CASE, PER IMAGING REVIEW BY THE EDWARDS MEDICAL DIRECTOR, POOR IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT LED TO THE 80:20 VENTRICULAR PLACEMENT OF THE SAPIEN VALVE. THE SUBSEQUENT CAI MAY HAVE BEEN RELATED TO NATIVE LEAFLET OVERHANG, ALTHOUGH TEE WAS NOT AVAILABLE TO CONFIRM THIS. THE MIGRATION MAY HAVE BEEN RELATED TO THE VENTRICULAR DEPLOYMENT AS WELL AS THE NATIVE LEAFLETS BEING FIBROTIC AND NOT CALCIFIED, AS EVIDENCED BY THE PHYSICIAN NOTING THAT THE LEAFLETS WERE SMOOTH DURING SURGERY; HOWEVER, THE PATHOLOGY REPORT TO CONFIRM THIS COULD NOT BE OBTAINED FOR REVIEW. OF NOTE, PER THE IFU THE SAFETY AND EFFECTIVENESS OF THE SAPIEN VALVE HAS NOT BEEN ESTABLISHED FOR PATIENTS WITH A NON CALCIFIED AORTIC ANNULUS. IT IS ALSO POSSIBLE THAT THE VALVE WAS UNDER DEPLOYED, AS THE OD MEASUREMENT UPON RETURN INDICATED AN UNEVEN AND UNDER DEPLOYMENT OF THE VALVE; HOWEVER, THE INITIAL VALVE OD POST DEPLOYMENT IN VIVO COULD NOT BE DETERMINED. ALTHOUGH IT CANNOT BE CONFIRMED, IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT'S UNDERLYING HEART DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED HEART BLOCK. THE RETURNED VALVE COULD NOT BE TESTED FOR FUNCTIONALITY AS THE LEAFLETS HAD BEEN PRESSED AGAINST THE FRAME BY THE DEPLOYMENT OF A SECOND VALVE. HOWEVER, A DHR REVIEW AND COMPLAINT HISTORY ANALYSIS DID NOT REVEAL ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE COULD HAVE POTENTIALLY BEEN RELATED TO THE EVENT. ALL VALVES ARE 100% VISUALLY INSPECTED UNDER MAGNIFICATION FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO DISTRIBUTION. THE COMPLAINT WAS CONFIRMED, BUT NO MANUFACTURING NON-CONFORMITIES WERE FOUND IN THE RETURNED SAMPLE. SINCE NO LABELING OR IFU INADEQUACIES HAVE BEEN IDENTIFIED, NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CINE AND ECHO IMAGES WERE SUBMITTED TO THE EDWARDS MEDICAL DIRECTOR FOR REVIEW. OBSERVATIONS: SEVERE AORTIC VALVE CALCIFICATION, MODERATE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MAC; BAVX2 DEMONSTRATED. 1ST WATERMELON SEEDED AORTIC. 2ND BAV STABLE; FAIR COAXIAL ALIGNMENT WITH SIGNIFICANT LATERAL BIAS; POOR IMAGE INTENSIFIER ANGLE (IIA). MIDDLE CUSP NOT IN PLANE AND SIGNIFICANTLY HIGHER THAN LATERAL AND MEDIAL CUSPS; POSITIONING IS TOO VENTRICULAR BUT ACTUAL RATIO IS DIFFICULT TO DETERMINE BASED ON POOR IIA; POST DEPLOYMENT VALVE POSITION IS APPROXIMATELY 80:20 VENTRICULAR THOUGH THE VALVE IS TILTED IN THE ANNULUS AND THEREFORE AN ACCURATE MEASUREMENT IS DIFFICULT TO DETERMINE; POST DEPLOYMENT AORTOGRAM DEMONSTRATES SIGNIFICANT AR; VALVE IN VALVE CINE DEMONSTRATES THE 2ND SAPIEN VALVE POSITIONED AND DEPLOYED MORE AORTIC (APPROX 65:35 VENTRICULAR) WITHIN THE 1ST DEPLOYED SAPIEN VALVE; NO POST DEPLOYMENT AORTOGRAM AVAILABLE. IMPRESSIONS: POOR IIA AND COAXIAL ALIGNMENT LEAD TO SAPIEN POSITIONING THAT WAS TOO VENTRICULAR (80:20 VENTRICULAR) SUBSEQUENT SIGNIFICANT CENTRAL AR MAY BE RELATED TO NATIVE LEAFLET OVERHANG ALTHOUGH NO TEE WAS AVAILABLE FOR REVIEW. LATER, VALVE IN VALVE POSITIONING WAS TOO VENTRICULAR (65:35 VENTRICULAR). AGREE WITH THE REPORTED CONTRADICTORY FINDINGS REGARDING INTRAPROCEDURAL TEE / FLOURO WITH DEGREE OF CALCIFICATION. THE INVESTIGATION IS ONGOING, PENDING EVALUATION OF THE DEVICES AND MEDICAL RECORDS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE SAPIEN VALVE WAS POSITIONED AND DEPLOYED 60:40 VENTRICULAR, RESULTING IN MODERATE CENTRAL AORTIC INSUFFICIENCY (CAI). THE PATIENT WAS HEMODYNAMICALLY STABLE AND THE CAI BEGAN TO IMPROVE, SO THE PHYSICIAN MADE THE DECISION TO NOT PERFORM ANY INTERVENTION AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. FIVE HOURS LATER THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND WAS EXPERIENCING RENAL FAILURE AND EPISODES OF COMPLETE HEART BLOCK (CHB). A SECOND SAPIEN VALVE WAS SUBSEQUENTLY IMPLANTED IN A MORE AORTIC POSITION, WHICH COMPLETELY RESOLVED THE CAI. THE PATIENT'S CONDITION STABILIZED AFTER THE SECOND VALVE WAS IMPLANTED. TWO DAYS FOLLOWING THE TAVR PROCEDURE, THE PATIENT AGAIN BECAME HEMODYNAMICALLY UNSTABLE AND THE PATIENT WAS ULTIMATELY TAKEN TO THE OPERATING ROOM WHERE A SURGICAL AORTIC VALVE REPLACEMENT WAS COMPLETED AND THE SAPIEN VALVES WERE EXPLANTED. IT APPEARED THE VALVES HAD MIGRATED. THE SURGEON STATED THAT ON INSPECTION THE NATIVE LEAFLETS APPEARED TO BE SMOOTH, WHICH WAS VERY UNUSUAL IN HIS EXPERIENCE. ON TEE, THE NATIVE AORTIC VALVE LEAFLETS APPEARED BULKY. THE NATIVE ANNULAR DIAMETER WAS 23MM BY TEE. THE NATIVE AORTIC ANNULUS WAS SEVERELY CALCIFIED. THE AORTIC ROOT WAS MODERATELY CALCIFIED. THE SINOTUBULAR JUNCTION (STJ) WAS MILDLY CALCIFIED WITH A DIAMETER OF 28MM. THE PATIENT'S EJECTION FRACTION WAS 45%. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. DURING VALVE DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155619 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention