BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3111292 · Received May 14, 2013

    Report

    Report Number
    2015691-2013-20071
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION, VALVE REGURGITATION AND CARDIOGENIC SHOCK ARE POTENTIAL ADVERSE EVENTS 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 AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. CARDIOGENIC SHOCK CAN HAVE MULTIPLE ETIOLOGIES, INCLUDING MYOCARDIAL INFARCTION, VENTRICULAR TACHYCARDIA, CARDIOMYOPATHY, AND DAMAGE TO THE HEART MUSCLE. IT IS MOST OFTEN DUE TO POOR VENTRICULAR FUNCTION. OTHER MAJOR RISK FACTORS THAT MAY PREDISPOSE A PATIENT TO CARDIOGENIC SHOCK INCLUDE ADVANCED AGE, A HISTORY OF HEART FAILURE, PREVIOUS MYOCARDIAL INFARCTION, AND CORONARY ARTERY DISEASE. IN ADDITION, PER THE IFU, CORONARY FLOW OBSTRUCTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO THE CORONARY OSTIA. IN ADDITION, CAUTION SHOULD BE EXERCISED IN IMPLANTING A BIOPROSTHESIS IN PATIENTS WITH CLINICALLY SIGNIFICANT CORONARY ARTERY DISEASE. CORONARY OBSTRUCTION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G. PTCA, IMPLANT OF A STENT, OR THROMBECTOMY). THERE ARE MULTIPLE PATIENT FACTORS WHICH COULD PUT THE PATIENT AT RISK FOR CORONARY FLOW OBSTRUCTION DURING THE TAVR PROCEDURE, INCLUDING SIGNIFICANT UNDERLYING CORONARY ARTERY DISEASE AND BULKY CALCIFICATION OF THE NATIVE LEAFLETS AND ROOT. DISPLACEMENT OF CALCIUM DEPOSITS WITH EMBOLIZATION OF DEBRIS INTO ONE OF THE ARTERIES, OR AORTIC DISSECTION WITH CONTINUITY OF THE RUPTURE INTO THE INTIMA OF ONE OF THE CORONARY OSTIA, CAN RESULT IN THIS COMPLICATION. THE EDWARDS THV MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. 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. IN THIS CASE, PER REPORT, THE 90:10 AORTIC IMPLANTATION OF THE VALVE MAY HAVE BEEN CAUSED BY LESS THAN OPTIMAL COMMUNICATION BETWEEN THE MEDICAL TEAM, WHICH MAY HAVE RESULTED IN LESS THAN OPTIMAL VALVE POSITIONING DURING DEPLOYMENT. IT IS ALSO POSSIBLE THAT A COMBINATION OF PATIENT FACTORS, SUCH AS A PERSEVERED EJECTION FRACTION (50%), ONLY MODERATE NATIVE VALVE CALCIFICATION, MILD MAC, AND MILD VENTRICULAR SEPTAL HYPERTROPHY, MAY HAVE ALSO CONTRIBUTED TO THE AORTIC MALPOSITION. ALTHOUGH THE CAUSE OF THE LAD OCCLUSION AND THE PATIENT'S HEMODYNAMIC COLLAPSE COULD NOT BE DETERMINED, VOLUME DEFICIENCY AND CORONARY SPASM OR EMBOLISM WERE REPORTEDLY POSSIBLE CONTRIBUTING FACTORS. IT IS ALSO POSSIBLE THAT THE EXTENDED LENGTH OF THE CASE DUE TO THE NEED FOR A SECOND VALVE MAY HAVE CONTRIBUTED TO THE PATIENT'S HEMODYNAMIC INSTABILITY. 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 EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR PROCEDURE THE 23 MM SAPIEN VALVE MOVED SLIGHTLY VENTRICULAR AT THE START OF THE INFLATION OF THE DELIVERY BALLOON. PRIOR TO COMPLETE DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO MOVE THE SAPIEN VALVE MORE AORTIC, WHICH RESULTED IN THE SAPIEN VALVE BEING IMPLANTED IN A 90:10 AORTIC POSITION. A SECOND SAPIEN VALVE WAS SUBSEQUENTLY DEPLOYED IN A MORE VENTRICULAR POSITION TO ENSURE THAT THE FIRST SAPIEN VALVE WAS PROPERLY ANCHORED INTO THE NATIVE AORTIC ANNULUS. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND HER HEMODYNAMICS WERE STABLE FOLLOWING DEPLOYMENT OF THE SECOND SAPIEN VALVE. NO PARAVALVULAR LEAK (PVL) OR CENTRAL AORTIC INSUFFICIENCY (CAI) WAS OBSERVED ON TEE OR ANGIOGRAM. GOOD CORONARY FLOW WAS OBSERVED IN BOTH THE LCA AND RCA DESPITE THE FIRST VALVE BEING IN A MORE AORTIC POSITION. THE APEX WAS CLOSED WITHOUT INCIDENT; HOWEVER, AFTER THE THORACOTOMY WAS COMPLETELY CLOSED, THE PATIENT BECAME HYPOTENSIVE, BRADYCARDIC AND HER LV FUNCTION WAS OBSERVED TO BE GREATLY DIMINISHED ON TEE. PHARMACOLOGICAL SUPPORT WAS GIVEN, ARTERIAL ACCESS WAS OBTAINED AND CORONARY FLOW WAS ASSESSED. THE RCA WAS OPEN, THE LCA WAS OPEN WITH DECENT FLOW, BUT THE DISTAL LAD, ALMOST AT THE LV APEX, HAD DIMINISHED FLOW. THE SOURCE OF THIS OCCLUSION WAS UNKNOWN. THE PHYSICIAN DECIDED NOT TO ATTEMPT TO OPEN THIS DISTAL LAD DUE TO ITS SMALL DIAMETER AND DISTAL LOCATION. AN INTRAAORTIC BALLOON PUMP (IABP) WAS INSERTED AND IMMEDIATE HEMODYNAMIC IMPROVEMENT WAS NOTED. DURING THIS TIME THE PATIENT ALSO DEVELOPED ATRIAL FIBRILLATION. THE PATIENT WAS CARDIOVERTED SEVERAL TIMES AND RETURNED TO SINUS RHYTHM. THE PATIENT WAS THEN TRANSFERRED TO THE CRITICAL CARE UNIT (CCU). THE PATIENT EXPIRED THE FOLLOWING MORNING. THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. THE NATIVE AORTIC ANNULAR DIAMETER WAS 21 MM BY TEE. THE NATIVE AORTIC VALVE WAS MODERATELY CALCIFIED. THE NATIVE AORTIC ROOT WAS MILDLY CALCIFIED. THERE WAS MILD MITRAL ANNULAR CALCIFICATION (MAC) AND MILD VENTRICULAR SEPTAL HYPERTROPHY. THE PATIENT'S EJECTION FRACTION WAS 50%. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. DURING DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. FOLLOWING THE PROCEDURE THE MEDICAL TEAM DISCUSSED THE PERCEIVED CAUSES OF THE AORTIC MALPOSITION AND THE PATIENT'S HEMODYNAMIC COLLAPSE. PER THIS DISCUSSION, IMPROVED COMMUNICATION AND MORE PRECISE VALVE POSITIONING DURING DEPLOYMENT MAY HAVE ALLOWED FOR A LESS AORTIC FINAL POSITION OF THE FIRST SAPIEN VALVE. ALTHOUGH THE CAUSE OF THE PATIENT'S HEMODYNAMIC COLLAPSE COULD NOT BE DETERMINED, VOLUME DEFICIENCY AND CORONARY SPASM OR EMBOLISM WERE POSSIBLE CONTRIBUTING FACTORS. IT WAS ALSO THOUGHT THAT THE EXTENDED LENGTH OF THE CASE DUE TO THE NEED FOR A SECOND VALVE MAY HAVE CONTRIBUTED TO THE DIFFICULTIES POST THORACOTOMY CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212109 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death