BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19397188 · Received May 24, 2024

    Report

    Report Number
    2025587-2024-03103
    Event Type
    Death
    Date Received
    May 24, 2024
    Date of Event
    March 2, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KHOA QUOC NGUYEN, DUONG VAN NGUYEN AND THUY THI LA ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS =80 AND <(><<)>80 YEARS OF AGE WITH AORTIC VALVE STENOSIS AT MODERATE SURGICAL RISK: FINDINGS FROM AN OBSERVATIONAL STUDY IN THE VIETNAMESE POPULATION. CVIA. 2024. VOL. 9(1). DOI: 10.15212/CVIA.2024.0003. 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE 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 THE EFFECTS OF AGE ON CLINICAL OUTCOMES IN VIETNAMESE PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). MEDTRONIC EVOLUT R/PRO (N = 87) AND NON-MEDTRONIC (N = 3) VALVE SYSTEMS WERE USED IN THE STUDY POPULATION OF 90 PATIENTS. THE AUTHORS OBSERVED A TOTAL OF NINE DEATHS, INCLUDING ONE PROCEDURAL DEATH (OCCURRED IN A SUBGROUP OF PATIENTS TREATED WITH EVOLUT R/PRO), FOUR CARDIOVASCULAR DEATHS WITHIN ONE YEAR OF TAVR, AND FOUR ALL-CAUSE DEATHS WITHIN ONE YEAR OF TAVR. ADDITIONAL ADVERSE OUTCOMES RECOUNTED IN THE ARTICLE: DISABLING STROKE, LIFE-THREATENING BLEEDING, MAJOR VASCULAR COMPLICATIONS, CORONARY ARTERY OBSTRUCTION REQUIRING INTERVENTION, VALVE MALPOSITIONING, COMPLETE ATRIOVENTRICULAR BLOCK, CONVERSION TO OPEN HEART SURGERY OR SURGICAL VALVE REPLACEMENT, MODERATE TO SEVERE PARAVALVULAR LEAK, IMPLANT OF TWO VALVES, NEED FOR PACEMAKER IMPLANTATION, AND HOSPITALIZATION FOR VALVE-RELATED SYMPTOMS OR WORSENING HEART FAILURE. NO ADDITIONAL ADVERSE OUTCOMES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623892 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death