BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 9673763 · Received February 5, 2020

    Report

    Report Number
    2025587-2020-00391
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    September 5, 2019
    Report Date
    February 5, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LADER JM ET AL. FACTORS PREDICTING PERSISTENCE OF AV NODAL BLOCK IN POST-TAVR PATIENTS FOLLOWING PERMANENT PACEMAKER IMPLANTATION. PACING CLIN ELECTROPHYSIOL. 2019 OCT;42(10):1347-1354. DOI: 10.1111/PACE.13789. EPUB 2019 SEP 5. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE INCIDENCE AND PREDICTORS OF PERSISTENT DEVICE DEPENDENCY IN PATIENTS WITH PERMANENT PACEMAKER IMPLANTATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A SELF-EXPANDING PROSTHESIS. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2014 AND MARCH 2017. THE OVERALL STUDY POPULATION INVOLVED 485 PATIENTS WITHOUT PRE-EXISTING PERMANENT PACEMAKERS. OF THOSE, 77 WERE INCLUDED IN THE STUDY ANALYSIS AND WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 84 YEARS. ALL PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 3 DEATHS WERE OBSERVED WITHIN 4 WEEKS POST-TAVR. NO FURTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: POST-TAVR PERMANENT PACEMAKER IMPLANTATION DUE TO COMPLETE HEART BLOCK (77 CASES). THE MEDIAN DURATION FROM TAVR TO PERMANENT PACEMAKER IMPLANTATION WAS ONE DAY. ADDITIONAL ADVERSE EVENTS THAT WERE OBSERVED: VALVE-IN-VALVE IMPLANTATION (2 CASES),MILD-MODERATE PARAVALVULAR LEAK (17 CASES), PERI-PROCEDURAL STROKE (UNKNOWN NUMBER OF CASES), ACUTE HEART FAILURE (2 CASES), CARDIOGENIC SHOCK (1 CASE), AND ABRUPT LOSS OF CONSCIOUSNESS (1 CASE). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS DIRECTLY 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
    133764 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention