BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14160069 · Received April 20, 2022

    Report

    Report Number
    2025587-2022-01024
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    December 27, 2021
    Report Date
    April 20, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BOGYI M, ET AL. SUBCLINICAL LEAFLET THROMBOSIS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: A META-ANALYSIS. JACC CARDIOVASC INTERV. 2021 DEC 27;14(24):2643-2656. DOI: 10.1016/J.JCIN.2021.09.019. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (PMA# P130021, PRODUCT CODE NPT), 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 FROM A LITERATURE ARTICLE REGARDING THE CLINICAL RELEVANCE OF SUBCLINICAL LEAFLET THROMBOSIS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WAS COLLECTED FROM A META-ANALYSIS REVIEW OF 25 STUDIES PUBLISHED BETWEEN 2015 AND 2020. THE TOTAL STUDY POPULATION INCLUDED 11,098 PATIENTS (DEMOGRAPHIC INFORMATION NOT REPORTED). AN UNSPECIFIED NUMBER OF THESE PATIENTS WERE IMPLANTED WITH A MEDTRONIC TRANSCATHETER VALVE (COREVALVE, EVOLUT R, OR EVOLUT PRO). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL MEDTRONIC TRANSCATHETER VALVE PATIENTS, THE INCIDENCE RATES OF SUBCLINICAL LEAFLET THROMBOSIS WERE AS FOLLOWS: COREVALVE = 1%, EVOLUT R = 5%, AND EVOLUT PRO = 0%. ADDITIONALLY, THE AUTHORS STATED THAT A SUBSET OF PATIENTS IN THE STUDY POPULATION, SOME WITH AND SOME WITHOUT A DIAGNOSIS OF SUBCLINICAL LEAFLET THROMBOSIS, DEVELOPED STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA) DURING FOLLOW-UP. ALTHOUGH A DIRECT CORRELATION WAS NOT MADE, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE OCCURRENCE OF STROKE OR TIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409361 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening