BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23424505 · Received October 30, 2025

    Report

    Report Number
    9617601-2025-02409
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    May 26, 2025
    Report Date
    October 30, 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
    PA, 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: GENERIC BRAND NAME: MEDTRONIC TRANSCATHETER DELIVERY SYSTEM, PRODUCT ID: MDT-TRANS DCS, SERIAL/LOT: UNKNOWN, USE BY DATE: UNKNOWN, UDI: UNKNOWN. CITATION: YAMASHITA Y, BAUDO M, SICOURI S, ET AL. CLINICAL OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH VARIOUS FLOW-GRADIENT AND EJECTION FRACTION PROFILES. ANATOL J CARDIOL. PUBLISHED ONLINE MAY 29, 2025. DOI:10.14744/ANATOLJCARDIOL.2025.5157 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. EARLIEST APPROVED EVOLUT PRO/PRO+/FX 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 THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH VARIOUS FLOW-GRADIENT AND EJECTION FRACTION PROFILES. THE OVERALL STUDY POPULATION CONSISTED OF 846 PATIENTS WHO UNDERWENT TAVR FOR SEVERE AORTIC STENOSIS. A MIX OF VALVE TYPES WERE USED IN THE STUDY, ENCOMPASSING VARIOUS MEDTRONIC (EVOLUT PRO/PRO+/FX, N = 380) AND NON-MEDTRONIC (SAPIEN 3/3 ULTRA, N = 466) BRANDS. THE FOLLOWING ADVERSE OUTCOMES OCCURRED: VALVE MALPOSITION, NEED FOR A SECOND VALVE, STROKE, MAJOR CARDIAC STRUCTURAL COMPLICATION, MAJOR VASCULAR COMPLICATION, NEED FOR PERMANENT PACEMAKER IMPLANTATION, HIGH MEAN GRADIENT (= 20 MM HG), AORTIC REGURGITATION (MILD TO SEVERE), REHOSPITALIZATION FOR HEART FAILURE, AND ACUTE KIDNEY INJURY. ADDITIONALLY, THE AUTHORS RECORDED OVERALL ONE- AND FIVE-YEAR MORTALITY RATES OF 13% AND 51%, RESPECTIVELY. 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
    1369659 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 82 YR Male Hospitalization| R| L "SEE H11...."