BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19521285 · Received June 12, 2024

    Report

    Report Number
    2025587-2024-03426
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    November 28, 2023
    Report Date
    June 12, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SUGIYAMA Y, MORIYAMA N, MIYASHITA H, ET AL. LONG-TERM ASSESSMENT OF SURVIVAL AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION - INSIGHTS FROM THE INTERNATIONAL TRANSCATHETER AORTIC VALVE IMPLANTATION REGISTRY. CIRC J. 2024;88(4):462-471. DOI:10.1253/CIRCJ.CJ-23-0593 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 A LONG-TERM ASSESSMENT OF SURVIVAL AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). MEDTRONIC (COREVALVE, EVOLUT R/PRO/PRO+) AND NON-MEDTRONIC (VARIOUS BRANDS) VALVE TYPES WERE USED IN THE STUDY POPULATION OF 2,414 PATIENTS. THE AUTHORS WROTE, ¿THE OVERALL SURVIVAL IN THE ENTIRE COHORT WAS 67.6% AT 5 YEARS, 44.8% AT 8 YEARS, AND 26.9% AT 10 YEARS.¿ NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC PRODUCT OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER OUTCOMES CONSISTED OF SECOND VALVE IMPLANT DURING TAVI, PARAVALVULAR LEAK (MODERATE TO SEVERE), VASCULAR COMPLICATIONS (MINOR OR MAJOR), BLEEDING COMPLICATIONS (MINOR, MAJOR, OR LIFE-THREATENING/DISABLING), RED BLOOD CELL TRANSFUSIONS, STROKE/TRANSIENT ISCHEMIC ATTACK, PERMANENT PACEMAKER IMPLANTATION, AND ACUTE KIDNEY INJURY. NO FURTHER ADVERSE OUTCOMES WERE NOTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395188 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| S