BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13430754 · Received February 2, 2022

    Report

    Report Number
    2025587-2022-00329
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    November 1, 2021
    Report Date
    February 2, 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: YOSHIJIMA N, ET AL. PREDICTORS AND CLINICAL OUTCOMES OF POOR SYMPTOMATIC IMPROVEMENT AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. OPEN HEART. 2021 NOV;8(2):E001742. DOI: 10.1136/OPENHRT-2021-001742. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT: NOVEMBER 1, 2021 (MONTH AND YEAR VALID). MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (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 PREDICTORS AND OUTCOMES OF POOR SYMPTOMATIC IMPROVEMENT AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM A JAPANESE MULTI-CENTER REGISTRY BETWEEN OCTOBER 2013 AND MAY 2017. OF THE 1,749 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE 84.5 YEARS), 232 WERE IMPLANTED WITH A MEDTRONIC TRANSCATHETER VALVE: COREVALVE (144) OR EVOLUT R (88). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. CUMULATIVE INCIDENCES OF ALL-CAUSE DEATH SINCE THE FIRST POST-PROCEDURAL YEAR WERE ESTIMATED AND SHOWN USING A ONE-YEAR LANDMARK ANALYSIS VIA THE KAPLAN-MEIER METHOD (FIGURE 2 AND FIGURE 3). HOWEVER, THE RATES WERE NOT CLEARLY NOTED IN THE ARTICLE TEXT. NO CORRELATION WAS MADE BETWEEN MEDTRONIC PRODUCT AND ANY DEATHS. NON-DEATH ADVERSE EVENTS INCLUDED: PERI-PROCEDURAL MYOCARDIAL INFARCTION, NEW PERMANENT PACEMAKER IMPLANTATION, NEW ATRIAL FIBRILLATION, NEW COMPLETE LEFT BUNDLE BRANCH BLOCK, STROKE, PATIENT-PROSTHESIS MISMATCH, MODERATE TO SEVERE PARAVALVULAR LEAK, MAJOR OR LIFE-THREATENING BLEEDING, MAJOR VASCULAR COMPLICATION, AND POOR SYMPTOMATIC IMPROVEMENT. POOR SYMPTOMATIC IMPROVEMENT WAS DEFINED AS READMISSION FOR HEART FAILURE WITHIN ONE YEAR AFTER TAVR OR NEW YORK HEART ASSOCIATION CLASS =3 AFTER ONE YEAR. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452459 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Hospitalization| R| L