BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 22287107 · Received June 18, 2025

    Report

    Report Number
    2025587-2025-04322
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 18, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME: MEDTRONIC TRANSCATHETER DELIVERY SYSTEM, PRODUCT ID: MDT-TRANS DCS, SERIAL/LOT: UNKNOWN, USE BY DATE: UNKNOWN, UDI: UNKNOWN. CITATION: RAJ R MAKKAR, ET AL. ACURATE NEO2 VALVE VERSUS COMMERCIALLY AVAILABLE TRANSCATHETER HEART VALVES IN PATIENTS WITH SEVERE AORTIC STENOSIS (ACURATE IDE): A MULTICENTRE, RANDOMISED, CONTROLLED, NON-INFERIORITY TRIAL. THE LANCET. JUNE 2025; VOLUME 405, ISSUE 10494, PAGES 2061-2074. DOI: 10.1016/S0140-6736(25)00319-8 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. EARLIEST APPROVED EVOLUT 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 A COMPARISON OF THE ACURATE NEO2 VALVE VERSUS COMMERCIALLY AVAILABLE SAPIEN AND EVOLUT VALVES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE EVOLUT GROUP CONSISTED OF 244 PATIENTS WHO UNDERWENT TAVR WITH A MEDTRONIC EVOLUT R, EVOLUT PRO, EVOLUT PRO+, OR EVOLUT FX VALVE. AMONG THE EVOLUT RECIPIENTS, ADVERSE OUTCOMES ENCOMPASSED: STROKE (DISABLING OR NON-DISABLING), REHOSPITALIZATION, MYOCARDIAL INFARCTION, VALVULOPLASTY OR SURGICAL REPLACEMENT FOR VALVE-RELATED DYSFUNCTION, NEED FOR PERMANENT PACEMAKER IMPLANTATION, NEW ATRIAL FIBRILLATION/FLUTTER, VALVE THROMBOSIS, BLEEDING (LIFE-THREATENING/DISABLING OR MAJOR), VASCULAR COMPLICATIONS (ACCESS SITE OR NON-ACCESS SITE), ENDOCARDITIS, VALVE MALPOSITION/ECTOPIC DEPLOYMENT, VALVE MIGRATION OR EMBOLIZATION, PARAVALVULAR LEAK (MODERATE OR GREATER), CENTRAL REGURGITATION (UNSPECIFIED SEVERITY), CORONARY OBSTRUCTION, AND CARDIAC TAMPONADE. ADDITIONALLY, EIGHT DEATHS OCCURRED WITHIN ONE YEAR OF VALVE IMPLANT. HOWEVER, NO EVIDENCE WAS PRESENTED TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684863 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H| S| L "SEE H11...."