BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3971824 · Received July 31, 2014

    Report

    Report Number
    2015691-2014-01753
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NON-FUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE VALVE THROMBOSIS IS UNKNOWN. HOWEVER, IT IS LIKELY THAT THE THROMBI ON THE VALVE CAUSED THE FUSION OF THE VALVE LEAFLETS.

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NON-FUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE VALVE THROMBOSIS UNKNOWN. IT IS POSSIBLE THAT THE VEGETATION IS RELATED TO THE RECENT STAFF INFECTION, BUT IT IS UNCONFIRMED WHICH CAME FIRST. THE VEGETATION ALONG WITH THROMBOSIS LIKELY CONTRIBUTED TO THE NON FUNCTIONING LEAFLET. 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VALVULAR THROMBOSIS AND EMBOLIZATION OF AIR, CALCIFICATION OR THROMBUS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. ACCORDING TO THE MAYO CLINIC, SOME CAUSES FOR THROMBOEMBOLISM INCLUDE ADVANCED AGE, ATHEROSCLEROSIS, CANCER, PREVIOUS MI, HEART FAILURE, DM, HTN, A SEDENTARY LIFESTYLE, CERTAIN MEDICATIONS, AND SMOKING. DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE VALVE THROMBOSIS IS UNKNOWN. HOWEVER, IT IS LIKELY THAT THE THROMBI ON THE VALVE CAUSED THE FUSION OF THE VALVE LEAFLETS AND THE SUBSEQUENT STROKE.

    Description of Event or Problem · 1

    ALMOST 7 MONTHS POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND IT WAS FOUND THAT THE ¿VALVE HAD CEASED TO FUNCTION.¿ TWO OF THE VALVE LEAFLETS WERE NOT WORKING. ONE MONTH POST TAVR, THE PATIENT HAD A MEAN GRADIENT OF 12MMHG AND THE VALVE WAS OPERATING VERY WELL, WITH ALL OF THE LEAFLETS FUNCTIONING. SEVEN MONTHS POST TAVR, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EKG CHANGES, SHORTNESS OF BREATH, AND PULMONARY EDEMA. A TEE WAS PERFORMED AND REVEALED POSSIBLE THROMBI AROUND THE SINUSES OF THE AORTIC VALVE AND TWO OF THE LEAFLETS WERE FUSED. THERE WAS VEGETATION NOTED ON THE MITRAL VALVE. THE PATIENT HAD DEVELOPED INCREASING CONFUSION WHICH WAS FURTHER INVESTIGATED WITH A CT OF THE BRAIN. THIS WAS NOTABLE FOR LINEAR BAND OF HYPOATTENUATION FOLLOWING A LEFT PARIETAL LOBE STROKE WHICH WAS SUGGESTIVE OF AN ACUTE INFARCT. MRI OF THE BRAIN WAS OBTAINED AND WAS NOTABLE FOR ACUTE INFARCTS IN THE LEFT PARIETAL LOBE AS WELL AS LEFT FRONTAL LOBE. THE PATIENT WAS GIVEN ANTI-COAGULANTS, BOTH TO PREVENT ANY FURTHER STROKES AS WELL AS TO POSSIBLY INCREASE VALVULAR FUNCTION. SHE THEN HAD A HEMORRHAGIC BLEED IN THE BRAIN. HER CONDITION CONTINUED TO DECLINE, AND THE TEAM DECIDED TO STOP CARE. IT WAS REPORTED THAT THERE WAS RECENT STREP ENDOCARDITIS FROM HER MITRAL VALVE, AND THE CEREBRAL EMBOLI WERE PROBABLY RELATED TO THAT.

    Description of Event or Problem · 1

    ALMOST 7 MONTHS POST PROCEDURE, THE PATIENT¿S WAS ADMITTED TO THE HOSPITAL, AND IT WAS FOUND THAT THE ¿VALVE HAD CEASED TO FUNCTION¿. TWO OF THE VALVE LEAFLETS WERE NOT WORKING. ONE MONTH POST TAVR, THE PATIENT HAD A MEAN GRADIENT OF 12MMHG AND THE VALVE WAS OPERATING VERY WELL, WITH ALL OF THE LEAFLETS FUNCTIONING. SEVEN MONTHS POST TAVR, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EKG CHANGES, SHORTNESS OF BREATH, AND PULMONARY EDEMA. A TEE WAS PERFORMED AND REVEALED POSSIBLE THROMBI AROUND THE SINUSES OF THE AORTIC VALVE AND TWO OF THE LEAFLETS WERE FUSED. THERE WAS VEGETATION NOTED ON THE MITRAL VALVE. THE PATIENT HAD DEVELOPED INCREASING CONFUSION WHICH WAS FURTHER INVESTIGATED WITH A CT OF THE BRAIN. THIS WAS NOTABLE FOR LINEAR BAND OF HYPOATTENUATION FOLLOWING A LEFT PARIETAL LOBE STROKE WHICH WAS SUGGESTIVE OF AN ACUTE INFARCT. MRI OF THE BRAIN WAS OBTAINED AND WAS NOTABLE FOR ACUTE INFARCTS IN THE LEFT PARIETAL LOBE AS WELL AS LEFT FRONTAL LOBE. THE PATIENT WAS GIVEN ANTI-COAGULANTS, BOTH TO PREVENT ANY FURTHER STROKES AS WELL AS TO POSSIBLY INCREASE VALVULAR FUNCTION. SHE THEN HAD A HEMORRHAGIC BLEED IN THE BRAIN. HER CONDITION CONTINUED TO DECLINE, AND THE TEAM DECIDED TO STOP CARE. IT WAS REPORTED THAT THERE WAS RECENT STREP ENDOCARDITIS FROM HER MITRAL VALVE, AND THE CEREBRAL EMBOLI WERE PROBABLY RELATED TO THAT.

    Description of Event or Problem · 1

    ALMOST 7 MONTHS POST PROCEDURE, THE PATIENT¿S WAS ADMITTED TO THE HOSPITAL, AND IT WAS FOUND THAT THE ¿VALVE HAD CEASED TO FUNCTION¿. TWO OF THE VALVE LEAFLETS WERE NOT WORKING. ONE MONTH POST TAVR, THE PATIENT HAD A MEAN GRADIENT OF 12MMHG AND THE VALVE WAS OPERATING VERY WELL, WITH ALL OF THE LEAFLETS FUNCTIONING. SEVEN MONTHS POST TAVR, THE PATIENT WAS ADMITTED TO THE HOSPITAL. A TEE WAS PERFORMED AND TWO OF THE LEAFLETS WERE FUSED. THERE WAS SOME CLOT AND VEGETATION ON THE SAPIEN VALVE, AND POSSIBLY SOME ON THE MITRAL VALVE. A CT SCAN AND MRI WERE PERFORMED THAT SHOWED SOME EMBOLIC EVENTS. THE PATIENT WAS GIVEN ANTI-COAGULANTS, BUT THEN HAD HEMORRHAGIC BLEED IN THE BRAIN. SHE HAD A DOWNHILL DECLINE FROM THERE, AND THE TEAM DECIDED TO STOP CARE. IT WAS REPORTED THAT THERE WAS A RECENT STAPH INFECTION POSSIBLY RELATED TO THE ENDOCARDITIS, HOWEVER THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446700 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention