BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23427217 · Received October 30, 2025

    Report

    Report Number
    9617601-2025-02427
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    August 27, 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
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KIKUCHI ET AL. REFINING BLEEDING RISK STRATIFICATION AFTER TAVR: ADDED VALUE OF CT-ADP BEYOND HIGH BLEEDING RISK CRITERIA. JACC CARDIOVASC INTERV. 2025 OCT 13;18(19):2371-2388. DOI: 10.1016/J.JCIN.2025.08.011. EPUB 2025 AUG 27. 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. 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 BLEEDING RISK STRATIFICATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION INCLUDED 884 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82.8 YEARS OLD. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; MEDTRONIC DEVICES INCLUDED COREVALVE, EVOLUT R, AND EVOLUT PRO BIOPROSTHETIC VALVES DELIVERED BY WAY OF A DELIVERY CATHETER SYSTEM (DCS). 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, CLINICAL OBSERVATIONS THAT MAY HAVE OCCURRED IN ASSOCIATION WITH A PROSTHETIC VALVE IMPLANTATION: BLOOD LOSS REQUIRING TRANSFUSION, PERICARDIAL BLEEDING, GASTROINTESTINAL BLEEDING, INTRACRANIAL BLEEDING, AND MODERATE TO SEVERE PARAVALVULAR LEAK. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS THAT MAY HAVE OCCURRED IN ASSOCIATION WITH A DCS: ACCESS SITE BLEEDING COMPLICATION REQUIRING INTERVENTION. NO FURTHER INFORMATION WAS PROVID ED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541526 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 83 YR Female Life Threatening| R| H