BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12807482 · Received November 12, 2021

    Report

    Report Number
    2025587-2021-03439
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    July 1, 2021
    Report Date
    November 12, 2021
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SABATINO ET AL. EARLY REDUCTION OF LEFT ATRIAL FUNCTION PREDICTS ADVERSE CLINICAL OUTCOMES IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT. OPEN HEART. 2021 JUL;8(2):E001685. DOI: 10.1136/OPENHRT-2021-001685. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING CLINICAL OUTCOMES IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER FROM DECEMBER 2016 TO FEBRUARY 2020. THE STUDY POPULATION INCLUDED 100 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81.2 YEARS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS 71 WERE IMPLANTED WITH A MEDTRONIC COREVALVE (N=1), EVOLUT R (N=69) OR EVOLUT PRO (N=1) BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 11 DEATHS OCCURRED DURING A MEDIAN FOLLOW-UP OF 31 MONTHS. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION THERE WAS NO CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATH(S). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MILD TO MODERATE AORTIC REGURGITATION (AR), AND ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705389 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT HEART VALVES SANTA ANA MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Life Threatening| H| R