BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 10344632 · Received July 30, 2020

    Report

    Report Number
    2015691-2020-12828
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 27, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 7 </NOE> EVENTS OF CORONARY COMPRESSION OR OBSTRUCTION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 7 EVENTS OF CORONARY COMPRESSION OR OBSTRUCTION FOR THE SAPIEN 3 VALVE IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4). "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: (1) AORTOGRAM OR TEE PRIOR TO 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. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS. 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

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR (B)(6) 2020 DATA EXTRACT FOR AORTIC SERIOUS INJURY EVENTS FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 7 EVENTS OF CORONARY COMPRESSION OR OBSTRUCTION IN THE AORTIC POSITION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE FOR (B)(6) 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 69-85. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 4 FEMALES AND 3 MALES. (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q4 2019 (OCTOBER 1 ¿ DECEMBER 31).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809923 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other