BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 16234846 · Received January 24, 2023

    Report

    Report Number
    2015691-2023-10325
    Event Type
    Death
    Date Received
    January 24, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 24, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (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 CORONARY OSTIA. CORONARY OCCLUSION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G. PCI). THERE ARE MULTIPLE PATIENT FACTORS THAT COULD CONTRIBUTE TO CORONARY OCCLUSION BY THE PROSTHETIC VALVE OR NATIVE VALVE LEAFLETS, INCLUDING A 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: AORTOGRAM OR TEE PRIOR TO THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS; DURING PRE-DILATATION, NOTE BULKY CALCIFICATION ON VALVE MOVING TOWARDS OSTIUM ON LEFT MAIN; AND CONSIDER AORTOGRAM DURING VALVULOPLASTY TO ASSESS CORONARY FLOW. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION THE CAUSE OF THE EVENT IS UNKNOWN BUT MAY BE RELATED TO THE FACTORS LISTED ABOVE. 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 · 0

    AS REPORTED FROM OUR AFFILIATES IN THE UNITED KINGDOM, THIS WAS A VALVE IN VALVE PROCEDURE OF A SAPIEN VALVE IN A NON-EDWARDS VALVE IN AORTIC POSITION BY TRANSFEMORAL APPROACH. DURING THE PROCEDURE, IMMEDIATELY AFTER VALVE DEPLOYMENT, THE PATIENT SUFFERED A TOTAL OCCLUSION OF THE LEFT CORONARY OSTIUM (DOMINANT SYSTEM). NO CORONARY FILLING WAS NOTED ON AORTOGRAM, AND THE LEFT CORONARY ARTERY COULD NOT BE ENGAGED WITH A CATHETER. AN UNSUCCESSFUL ATTEMPT TO DRAG THE EDWARDS VALVE OUT OF SITU WAS PERFORMED BY RE-INFLATING THE COMMANDER DELIVERY SYSTEM BALLOON. THE VALVE WAS NOT EXPLANTED, AND NO FURTHER ACTIONS WERE PERFORMED AFTER THE UNSUCCESSFUL ATTEMPT TO DRAG THE VALVE. THE PATIENT PASSED AWAY. POTENTIALLY, THE SAPIEN VALVE WAS IMPLANTED TOO HIGH, AND OVERSIZED, AS A 23MM VS 26MM WOULD HAVE BEEN A MORE SUITABLE CHOICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619450 N/A AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D