BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 11310280 · Received February 10, 2021

    Report

    Report Number
    2025587-2021-00506
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    May 23, 2019
    Report Date
    February 10, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MICHEL J ET AL. THE CLINICAL IMPACT OF PSOAS MUSCLE CROSS-SECTIONAL AREA ON MEDIUM-TERM MORTALITY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. HEART LUNG CIRC. 2020 JUN;29(6):904-913. DOI: 10.1016/J.HLC.2019.05.095. EPUB 2019 MAY 23. 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 · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE IMPACT OF PSOAS MUSCLE CROSS-SECTIONAL AREA ON MORTALITY WITHIN FIVE YEARS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER REGISTRY BETWEEN 2007 AND APRIL 2015. THE STUDY POPULATION INCLUDED 1,731 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEDIAN AGE OF 81 YEARS. OF THOSE, 643 WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 555 ALL-CAUSE DEATHS OCCURRED DURING THE MEAN FOLLOW-UP OF 775 DAYS. MULTIPLE MANUFACTURERS TRANSCATHETER VALVES WERE IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CONVERSION TO SURGERY DURING TAVI, UNSPECIFIED NEED FOR VALVE-IN-VALVE IMPLANTATION DURING TAVI, AND MODERATE TO SEVERE AORTIC REGURGITATION (DETECTED ON PRE-DISCHARGE ECHOCARDIOGRAPHY). 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
    206202 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention