BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14401228 · Received May 13, 2022

    Report

    Report Number
    2025587-2022-01355
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    February 15, 2021
    Report Date
    May 13, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: IMAMURA T.; ET AL. CLINICAL IMPLICATIONS OF TROPONIN-T ELEVATIONS FOLLOWING TAVR: TROPONIN INCREASE FOLLOWING TAVR. J. CAR DIOL., 2022 FEB 01; 79(2):240-246. DOI: 10.1016/J.JJCC.2021.08.030. PMID: 34538533. EPUB 2021 SEP 15. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R, EVOLUT PRO, EVOLUT PRO+ (PMA# P130021, PRODUCT CODE: NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 BASED UPON TROPONIN-T LEVELS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE PROSPECTIVELY COLLECTED FROM A SINGLE CENTER, WITH DATA COLLECTION ENDING IN MAY 2021. THE STUDY POPULATION INCLUDED 189 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 86 YEARS), 110 OF WHOM WERE IMPLANTED WITH MEDTRONIC SELF-EXPANDING BIOPROSTHETIC VALVES, WHICH INCLUDED THE COREVALVE, EVOLUT R/PRO/PRO+ MODELS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 2 CARDIOVASCULAR-RELATED DEATHS OCCURRED OVER A 2-YEAR POST-TAVR FOLLOW-UP PERIOD. NO FURTHER INFORMATION ON THE DEATHS WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: HOSPITAL RE-ADMISSIONS FOR HEART FAILURE, NEED FOR PERMANENT PACEMAKER IMPLANTATION, DI SABLING/NON-DISABLING STROKES, WORSENING HEART FAILURE AND MAJOR VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395587 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention| S| H