BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12392656 · Received August 31, 2021

    Report

    Report Number
    2025587-2021-02697
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    April 14, 2021
    Report Date
    August 31, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ATTINGER-TOLLER A, ET AL. AGE-RELATED OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: INSIGHTS FROM THE SWISSTAVI REGISTRY. JACC CARDIOVASC INTERV. 2021 MAY 10;14(9):952-960. DOI: 10.1016/J.JCIN.2021.01.042. EPUB 2021 APR 14. 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 · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE AGE-RELATED OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM A NATIONAL FIFTEEN-CENTER REGISTRY BETWEEN FEBRUARY 2011 AND JUNE 2018. OF THE 7 ,097 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE, MEAN AGE 82 YEARS), 2,264 UNDERWENT TAVR WITH THE MEDTRONIC COREVALVE (922), EVOLUT R (1,123), OR EVOLUT PRO (219). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, A TOTAL OF 1,411 DEATHS (ALL-CAUSE = 838, CARDIOVASCULAR = 573) OCCURRED WITHIN ONE YEAR OF TAVR. NO CORRELATION WAS MADE BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS THAT OCCURRED WITHIN ONE YEAR OF TAVR (IN-HOSPITAL, THIRTY-DAY FOLLOW-UP, AND ONE-YEAR FOLLOW-UP, RESPECTIVELY): CEREBROVASCULAR ACCIDENT; DISABLING STROKE; MYOCARDIAL INFARCTION (PERI-PROCEDURAL OR SPONTANEOUS); PERMANENT PACEMAKER IMPLANTATION; MILD TO SEVERE AORTIC REGURGITATION; NEED FOR BLOOD TRANSFUSION; BLEEDING (LIFE-THREATENING OR MAJOR); AND UNSPECIFIED ACCESS-RELATED COMPLICATIONS/MAJOR COMPLICATIONS (NO INTERVENTIONS WERE REPORTED TO HAVE BEEN PERFORMED AS A RESULT). 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
    1292043 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R| S