BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23685617 · Received December 1, 2025

    Report

    Report Number
    9617601-2025-03098
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    July 23, 2025
    Report Date
    December 1, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LI W, JIA Y, LI H, ET AL. LONG-TERM OUTCOMES OF BAV-0 PATIENTS COMPARED WITH BAV-1 AND TAV PATIENTS AFTER TAVR. JACC CARDIOVASC INTERV. 2025;18(15):1881-1892. DOI:10.1016/J.JCIN.2025.05.045 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. EARLIEST APPROVED COREVALVE/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 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH TRICUSPID AND BICUSPID AORTIC VALVE SUBTYPES. A TOTAL OF 2,553 TAVR PATIENTS WERE INCLUDED IN THE STUDY POPULATION. A MIX OF VALVE TYPES WERE USED FOR TAVR, ENCOMPASSING THREE MEDTRONIC PRODUCTS (COREVALVE/EVOLUT R/EVOLUT PRO, N = 216) AND SEVERAL NON-MEDTRONIC BRANDS (N = 2,337). THE FOLLOWING POST-TAVR OUTCOMES WERE RECORDED: PARAVALVULAR LEAK (MODERATE TO SEVERE), PERMANENT PACEMAKER IMPLANTATION, AND HIGH GRADIENTS (= 20 MMHG). ADDITIONALLY, 855 DEATHS OCCURRED DURING THE LONG-TERM FOLLOW-UP. HOWEVER, NO EVIDENCE WAS PRESENTED TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN A MEDTRONIC PRODUCT AND ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092548 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| L