BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3

    MDR report key: 10886778 · Received November 23, 2020

    Report

    Report Number
    2015691-2020-14622
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    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

    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> 3 </NOE> EVENTS OF CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE IN THE MITRAL POSITION FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 3 EVENTS OF CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE MITRAL POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 14. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (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

    THIS REPORT SUMMARIZE 3 EVENTS OF CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE IN THE MITRAL POSITION FOR AUGUST 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 60 TO 73. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 MALES AND 1 FEMALES. AUGUST 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q1 (JANUARY 1 AND MARCH 31).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353583 EDWARDS SAPIEN 3 PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other N/A.