BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13060184 · Received December 22, 2021

    Report

    Report Number
    2025587-2021-03819
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    January 1, 2019
    Report Date
    December 22, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CHOI JY, ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT WITH MINIMAL CONTRAST DYE IN PATIENTS WITH RENAL INSUFFICIENCY. YONSEI MED J. 2021 NOV;62(11):990-996. DOI: 10.3349/YMJ.2021.62.11.990. PRESENTED AT THE AMERICAN HEART ASSOCIATION (AHA) SCIENTIFIC SESSIONS 2019 AND THE KOREAN SOCIETY OF CARDIOLOGY (KSC) 2019. EARLIEST DATE OF PRESENTATION USED FOR DATE OF EVENT: JANUARY 1, 2019 (YEAR VALID). 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 PATIENT OUTCOMES OF MINIMAL CONTRAST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) COMPARED TO CONVENTIONAL TAVR. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JULY 2011 AND APRIL 2020. OF THE 93 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE; MEAN AGE 82.3 YEARS; MEAN WEIGHT 57.1 KG), 82 WERE IMPLANTED WITH A MEDTRONIC TRANSCATHETER VALVE: COREVALVE (N = 23), EVOLUT R (N = 49), OR EVOLUT PRO (N = 10). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS INCLUDED IN THE STUDY, 9 ALL-CAUSE DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVR. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS INCLUDED IN THE STUDY, ADVERSE EVENTS THAT OCCURRED WITHIN THIRTY DAYS OF TAVR INCLUDED: PERMANENT PACEMAKER IMPLANTATION, STROKE, AND MILD TO SEVERE PARAVALVULAR LEAK. 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
    1964658 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 Female Life Threatening| R