BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19461063 · Received June 4, 2024

    Report

    Report Number
    2025587-2024-03252
    Event Type
    Death
    Date Received
    June 4, 2024
    Date of Event
    March 10, 2024
    Report Date
    June 4, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: STACHEL G, JENTZSCH M, OEHRING M, ET AL. RED BLOOD CELL DISTRIBUTION WIDTH (RDW) IS ASSOCIATED WITH UNFAVORABLE FUNCTIONAL OUTCOME AFTER TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION. INT J CARDIOL HEART VASC. 2024;51:101383. PUBLISHED 2024 MAR 10. DOI:10.1016/J.IJCHA.2024.101383 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021) AND EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE IMPACT OF PRE-PROCEDURAL RED BLOOD CELL DISTRIBUTION WIDTH LEVELS ON PATIENT OUTCOMES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). MEDTRONIC (EVOLUT R/PRO = 71) AND NON-MEDTRONIC (VARIOUS = 102) VALVE TYPES WERE IMPLANTED IN THE STUDY POPULATION OF 176 PATIENTS. DURING FOLLOW-UP, THE AUTHORS OBSERVED AND RECORDED ALL-CAUSE (N = 12), CARDIOVASCULAR (N = 1), AND VALVE-RELATED (N = 1) DEATHS, RESPECTIVELY. OTHER ADVERSE EVENTS MENTIONED BY THE AUTHORS: BLEEDING; MAJOR VASCULAR COMPLICATIONS; ACUTE KIDNEY INJURY (STAGE 3 OR 4); STROKE; NEED FOR PERMANENT PACEMAKER IMPLANTATION; PARAVALVULAR LEAK (TRACE TO MODERATE); AND HOSPITALIZATIONS FOR CARDIOVASCULAR, HEART FAILURE, OR VALVE-RELATED REASONS. NO FURTHER SPECIFICS WERE NOTED IN THE ARTICLE ABOUT ANY OF THE ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149183 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Life Threatening| D