BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 15632945 · Received October 19, 2022

    Report

    Report Number
    2015691-2022-08687
    Event Type
    Death
    Date Received
    October 19, 2022
    Date of Event
    October 21, 2021
    Report Date
    December 22, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE WAS ACCEPTED FOR PUBLICATION ON MARCH 1, 2022. THEREFORE, THE 'SUBMISSION FOR PUBLICATION DATE' WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CAUTIONS THAT SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO CORONARY OSTIA. IN ADDITION, IT WARNS THAT 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. PERCUTANEOUS CORONARY INTERVENTION (PCI)). MULTIPLE PATIENT FACTORS COULD PUT THE PATIENT AT RISK FOR CORONARY FLOW OBSTRUCTION DURING THE THV 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. ADDITIONALLY, MINIMAL DISTANCE BETWEEN THE NATIVE ANNULUS AND THE CORONARY OSTIA, BULKY CALCIFICATION, LONG NATIVE LEAFLETS, AND OBLITERATED CORONARY SINUSES. PROCEDURAL FACTORS SUCH AS TORN NATIVE LEAFLET DURING BAV, PLAQUE SHIFT, DEPLOYMENT OF THE BIOPROSTHETIC HEART VALVE TOO AORTIC, AND SIGNIFICANT VALVE OVER SIZING COULD ALSO CONTRIBUTE TO THIS COMPLICATION. THE EDWARDS THV TRAINING 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. THE PHYSICIAN IS INSTRUCTED TO EVALUATE THIS RISK EARLY IN THE PATIENT SCREENING PROCESS IN ALL PATIENTS THE FOLLOWING FACTORS SHOULD BE CONSIDERED: DEGREE OF CALCIFICATION ON LEAFLETS, ANNULUS TO CORONARY OSTIA DISTANCE, LENGTH OF THE VALVE LEAFLET, WIDTH OF THE VALSALVA SINUSES, MOVEMENT OF THE LEAFLETS DURING BAV, PATENCY OF CORONARIES DURING BAV, AND EXPANDED HEIGHT OF THE INTENDED THV. THE TRAINING MANUALS ALSO PROVIDE THE FOLLOWING TIPS FOR DETECTING RISK FOR LEFT MAIN OCCLUSION: (1) AORTOGRAM OR TEE BEFORE THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS; (2) DURING PRE-DILATATION, NOTE BULKY CALCIFICATION ON VALVE MOVING TOWARDS OSTIUM ON LEFT MAIN; AND (3) CONSIDER AORTOGRAM DURING VALVULOPLASTY TO ASSESS CORONARY FLOW. THE EDWARDS THV MANUALS ALSO 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. PER THE INSTRUCTIONS FOR USE (IFU), CORONARY OBSTRUCTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE PRE-EXISTING VALVE LIKELY CONTRIBUTED TO THE EVENT . A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. NO INDICATION OF EXPLANT.

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION, IN THIS CASE, REGARDING THE ROOT CAUSE, THE HEIGHT AND CAUSE OF THE OBSTRUCTION, THE MAIN TRUNK OCCLUSION FROM ACUTE SEQUESTRATION OF BLOOD FLOW WITHIN THE LEFT SINUS OF VALSALVA FOR SEALING AT THE LEVEL OF THE SINO-TUBULAR JUNCTION (PROSTHESIS USED IN THE CONTEXT OF ACUTE VIV TREATMENT OF POP-UP OF ANOTHER AORTIC BIOPROSTHESIS).

    Additional Manufacturer Narrative · 0

    UPDATE TO B4, G3, G6, AND H10 TO REFLECT IMAGING REVIEW. IMAGES FROM THE ARTICLE WERE REVIEWED BY AN EDWARDS PHYSICIAN, AND THE FOLLOWING OBSERVATIONS AND IMPRESSIONS WERE PROVIDED: CONFIRMATION OF THE CONCLUSION OF THE ARTICLE THAT THE SECOND DEVICE IMPLANTED (SAPIEN 3 ULTRA) CREATED THE LEFT MAIN OCCLUSION. NO ADDITIONAL INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 0

    AS REPORTED BY OUR AFFILIATES IN ITALY, THROUGH THE REVIEW OF THE MEDICAL ARTICLE: "SINUS OF VALSALVA SEQUESTRATION FOLLOWING TRANSCATHETER-BASED MANAGEMENT OF ACURATE NEO2 VALVE EMBOLIZATION", CORRESPONDING AUTHOR DR. MARCO BARBANTI FROM A.O.U. POLICLINICO "G. RODOLICO-SAN MARCO", A NEGATIVE INTERATION OCCURRED BETWEEN AN EDWARDS SAPIEN 3 ULTRA VALVE AND A NON-EDWARDS VALVE. CASE OF A 81-YEAR-OLD-WOMAN WHO UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH AN ACURATE NEO 2 SIZE S. AFTER DEPLOYMENT, THE PROSTHESIS LOST CONTACT WITH THE ANNULUS, RESULTING IN SEVERE AORTIC REGURGITATION. THE EMBOLIZED ACURATE REMAINED WITHIN THE AORTIC ROOT, TILTED TOWARD THE LEFT SINUS. BECAUSE OF HEMODYNAMIC DETERIORATION, IT WAS DECIDED TO PROCEED WITH TAVR-IN-TAVR USING 23-MM SAPIEN 3 ULTRA. DESPITE THE VALVE PLACEMENT, THE PATIENT'S HEMODYNAMIC STATUS FURTHER DETERIORATED. A NEW AORTOGRAM SHOWED NO FLOW INTO THE LEFT MAIN CORONARY ARTERY. IT WAS ATTEMPTED TO REENGAGE THE LEFT MAIN CORONARY ARTERY, BUT CATHETERS WOULD NOT PASS THROUGH THE PROFILE OF THE ACURATE VALVE. THE PATIENT DIED SOON THEREAFTER. THE SAPIEN 3 ULTRA VALVE IMPLANTED DISPLACED THE LEAFLETS OF THE NON-EDWARDS VALVE, CREATING A BARRIER THAT EXTENDED INTO THE ASCENDING AORTA. THIS NEOTUBE RESTRICTED CORONARY BLOOD FLOW, REQUIRING IT TO BE SUPPLIED FROM ABOVE. HOWEVER, THIS NEOSINUS FLOW WAS MARKEDLY LIMITED BY THE SMALL DIMENSIONS OF THE STJ.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION, REGARDING THE HEIGHT AND CAUSE OF THE OBSTRUCTION, THE MAIN TRUNK OCCLUSION FROM ACUTE SEQUESTRATION OF BLOOD FLOW WITHIN THE LEFT SINUS OF VALSALVA FOR SEALING AT THE LEVEL OF THE SINO-TUBULAR JUNCTION (PROSTHESIS USED IN THE CONTEXT OF ACUTE VIV TREATMENT OF POP-UP OF ANOTHER AORTIC BIOPROSTHESIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223004 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death| R