BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 12640348 · Received October 15, 2021

    Report

    Report Number
    2015691-2021-05689
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    July 1, 2021
    Report Date
    November 17, 2021
    Manufacturer
    EDWARD LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW OF THE LATEST TVT REGISTRY DATA RECEIVED, ADDITIONAL EVENTS WERE IDENTIFIED, SO THE FOLLOWING FIELDS HAVE BEEN UPDATED. (B5, H10). THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 3.63.

    Additional Manufacturer Narrative · 0

    RESUBMITTING CORRECTED MDR TO PROVIDE EXEMPTION NUMBER IN PROVIDED FIELD. NO NEW INFORMATION TO REPORT.

    Description of Event or Problem · 0

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR Q3 2021 DATA EXTRACT FOR AORTIC SERIOUS INJURIES FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 719 PERMANENT PACEMAKER EVENTS FOR THE SAPIEN 3 ULTRA VALVE. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 397 MALES AND 322 FEMALES.

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 894 EVENTS OF PERMANENT PACEMAKER EVENTS FOR THE SAPIEN 3 ULTRA HEART VALVE IN THE AORTIC POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 3.58. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4), (B)(4) , (B)(4). PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INVASIVE CARDIAC INTERVENTIONS, INCLUDING THE USE OF TRANSCATHETER HEART VALVES. CONDUCTION SYSTEM DISTURBANCES DURING TMVR MAY BE RELATED TO SEVERAL PATIENT FACTORS (PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE MITRAL ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES) AND PROCEDURAL FACTORS (DEPTH AND PROFILE OF THE IMPLANTED PROSTHESIS, SHEATH, WIRE AND DELIVERY SYSTEM MANIPULATION). IN THIS CASE, SPECIFIC PATIENT AND PROCEDURAL FACTORS ARE NOT AVAILABLE; HOWEVER, THE CONDUCTION DISTURBANCE MAY BE RELATED TO THE POTENTIAL CONTRIBUTING FACTORS DESCRIBED 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 AT THIS TIME.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR Q3 2021 DATA EXTRACT FOR AORTIC SERIOUS INJURIES FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 894 PERMANENT PACEMAKER EVENTS FOR THE SAPIEN 3 ULTRA VALVE. THE AGE RANGE FOR THESE EVENTS IS FROM 50 TO 103. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 488 MALES AND 406 FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540861 SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARD LIFESCIENCES LLC 9750TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Other