BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPIEN M3 VALVE

    MDR report key: 16587266 · Received March 21, 2023

    Report

    Report Number
    2015691-2023-11748
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    November 19, 2022
    Report Date
    April 5, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103214291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS PREVIOUSLY REPORTED BY EDWARDS LIFESCIENCES UNDER MANUFACTURER REPORT # 2015691-2023-11748. ADDITIONAL INFORMATION OBTAINED THROUGH MEDICAL RECORDS OF THE TAVR PROCEDURE AND FOLLOW-UP VISITS CLARIFIED THAT THERE APPEARS TO BE THICKENED LEAFLETS RELATED TO HALT AND MOTION RESTRICTION WITH SEVERE STENOSIS AND MILD CENTRAL REGURGITATION OF THE M3 VALVE. THESE EVENTS ARE NOT REPORTABLE AS THIS TIME, AS THERE IS NO SCHEDULED OR PLANNED INTERVENTION. BASED ON THESE RESULTS, THIS COMPLAINT IS NO LONGER CONSIDERED TO BE A REPORTABLE EVENT AND A CORRECTED REPORT IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE, SAPIEN M3 VALVE, MODEL: 9880TFX29MCLUS, IS NOT SOLD OR MARKETED IN THE US; HOWEVER, IT IS DEEMED SIMILAR TO THE SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL: 9600TFX29, PMA#: P140031. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    AS REPORTED VIA ENCIRCLE STUDY, A TTE WAS COMPLETED 3 DAYS POST PROCEDURE FOR A 29MM SAPIEN M3 VALVE AND NOTED "MODERATE PROSTHETIC MITRAL VALVE STENOSIS WITH A MEAN GRADIENT OF 9.4MMHG AT A HR OF 62BPM. CLINICALLY SIGNIFICANT." THERE IS NO REPORT OF INTERVENTION OR TREATMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24398 SAPIEN M3 VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9880TFX29MCLUS NA 00690103214291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown