BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20324190 · Received September 27, 2024

    Report

    Report Number
    2025587-2024-05386
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 27, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ONISHI, ET AL. TRANSCATHETER AORTIC VALVE IMPLANTATION IN JAPANESE PATIENTS WITH LARGE ANNULUS: THE OCEAN-TAVI REGISTRY. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 4: 9, 686-694 2024. DOI.ORG/10.1016/J.JACASI.2024.07.002. EARLIEST DATE OF PUBLICATION 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. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN JAPANESE PATIENTS WITH LARGE NATIVE ANNULUS. THE STUDY POPULATION INCLUDED 773 PATIENTS.  MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 102 PATIENTS WERE IMPLANTED WITH A MEDTRONIC CORE VALVE (N=8), EVOLUT R (N=55), OR EVOLUT PRO (N=39) BIOPROSTHETIC VALVE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS IN THE SELF-EXPANDABLE VALVE GROUP, ADVERSE EVENTS INCLUDED: ELEVATED PEAK GRADIENTS 16 MM HG, MODERATE OR GREATER PARAVALVULAR LEAK, SEVERE PATIENT-PROSTHESIS MISMATCH, MAJOR VASCULAR COMPLICATION, CORONARY OCCLUSION, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STROKE, AND ACUTE KIDNEY INJURY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664809 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| H| R