BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 17175410 · Received June 21, 2023

    Report

    Report Number
    2015691-2023-14081
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    August 1, 2015
    Report Date
    June 21, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ARTICLE OKAJIMA, KAZUE, IKKI KOMATSU, AND TODD B. SETO. LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3. INTERNATIONAL JOURNAL OF ANGIOLOGY 31.02 (2021): 120-125. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM AUGUST 2015 TO DECEMBER 2017. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-AUGUST 2015) WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THE IFU CAUTIONS THAT SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS NEAR 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 BALLOON VALVULOPLASTY, 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE CAUSE TO THE EVENT IS UNKNOWN. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, PER ARTICLE, "LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3'', THE STUDY INCLUDES A TOTAL OF 201 PATIENTS WHO WERE TREATED WITH SAPIEN 3 VALVE (SP3) FROM AUGUST 2015 TO DECEMBER 2017 AT THE QUEENS MEDICAL CENTER, HONOLULU, HI. THE STUDY INCLUDED 21 PATIENTS WITH 20MM SAPIEN 3 VALVES, 67 WITH 23MM SAPIENT 3 VALVES, AND 113 WITH 26 OR 29MM SAPIEN 3 VALVES. EVENTS WERE CAPTURED FROM TABLE 2 PROCEDURAL OUTCOMES AND TABLE 3 HEMODYNAMIC PARAMETERS (POSTPROCEDURAL). THIS EVENT IS FOR AFTER IMPLANTATION OF A 23MM SAPIEN 3 VALVE,1 PATIENT HAS A CORONARY OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421717 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other