BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 24793925 · Received April 6, 2026

    Report

    Report Number
    9617601-2026-02289
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    February 8, 2026
    Report Date
    April 6, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TENG ET AL. THE VERIFICATION OF CO-AXIALITY OF THE THREE SELF-EXPANDING TRANSCATHETER AORTIC VALVE SYSTEMS ACCORDING TO THE DIFFERENCE IN SHAFT SPINE. CATHETER CARDIOVASC INTERV. 2026 APR;107(5):1537-1546. DOI: 10.1002/CCD.70512. EPUB 2026 FEB 8. 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 THE CO-AXIALITY OF THREE SELF-EXPANDING TRANSCATHETER AORTIC VALVE SYSTEMS ACCORDING TO THE DIFFERENCE IN SHAFT SPINE.  THE STUDY POPULATION INCLUDED 95 TOTAL PATIENTS.  MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 62 PATIENTS RECEIVED A MEDTRONIC EVOLUT PRO+ (N=41) OR EVOLUT FX (N=21) BIOPROSTHETIC TRANSCATHETER VALVE.  AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: PEAK TRANSVALVULAR GRADIENTS OF  12.0 MMHG, MILD OR GREATER PARAVALVULAR LEAK (PVL), AND ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851710 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 NA Unknown Life Threatening| H| R