BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 24307519 · Received February 10, 2026

    Report

    Report Number
    9617601-2026-01097
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    September 22, 2025
    Report Date
    February 10, 2026
    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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CHEDID ET AL. EARLY BIOPROSTHETIC VALVE DETERIORATION WITHIN 5 YEARS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. CAN J CARDIOL. 2025 DEC;41(12):2388-2396. DOI: 10.1016/J.CJCA.2025.09.027. EPUB 2025 SEP 22. 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 EARLY BIOPROSTHETIC VALVE DETERIORATION WITHIN FIVE YEARS FOLLOWING TRANSCATHETER AORTIC VALVE REP LACEMENT (TAVR).  THE STUDY POPULATION INCLUDED 306 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 81 YEARS OLD.  MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; MEDTRONIC DEVICES INCLUDED COREVALVE, EVOLUT R, OR EVOLUT PRO BIOPROSTHETIC VALVES.   THE AUTHORS DEFINED BIOPROSTHETIC VALVE FAILURE AS IRREVERSIBLE HEMODYNAMICALLY-SIGNIFICANT BIOPROSTHETIC VALVE DETERIORATION, VALVE REINTERVENTION, OR VALVE-RELATED DEATH.  THIS DEFINITION SUGGESTS A POTENTIAL ASSOCIATION BETWEEN MEDTRONIC PRODUCTS AND PATIENT DEATHS.  HOWEVER, THERE WERE NO FURTHER STATEMENTS ESTABLISHING A DIRECT CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.   AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: EARLY BIOPROSTHETIC VALVE DETERIORATION, HYPOATTENUATED LEAFLET THICKENING (HALT), HEMODYNAMIC VALVE DETERIORATION,  MYOCARDIAL INFARCTION (MI), STROKE, ENDOCARDITIS, CONGESTIVE HEART FAILURE (CHF), VALVE-IN-VALVE FOR UNSPECIFIED REASON AND VALVE-RELATED REINTERVENTION.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363151 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 81 YR Male Hospitalization| R| L