BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 24626057 · Received March 18, 2026

    Report

    Report Number
    9617601-2026-01864
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    January 2, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LUPU L, ROGERS T, ABUSNINA W, ET AL. CORONARY ACCESS AFTER TAVR WITH THE 4TH AND 5TH -GENERATION SELF-EXPANDING EVOLUT VALVES: THE EPROMPT-CA STUDY. INT J CARDIOL. 2026; 448:134073. DOI: 10.1016/J.IJCARD.2025.134073. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. EARLIEST APPROVED EVOLUT FX/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 CORONARY ACCESS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH MEDTRONIC EVOLUT FX/FX+ VALVES. A TOTAL OF 143 PATIENTS WHO UNDERWENT TAVR WITH AN EVOLUT FX (N = 103) OR FX+ (N = 40) VALVE WERE INCLUDED IN THE STUDY POPULATION. AMONG ALL EVOLUT FX/FX+ PATIENTS, THE FOLLOWING POST-TAVR OBSERVATIONS WERE NOTED IN THE ARTICLE: UNSUCCESSFUL CORONARY ACCESS, VALVE COMMISSURAL MISALIGNMENT, CONSTRAINED VALVE FRAME, AND ACUTE KIDNEY INJURY (NO INTERVENTION WAS RECOUNTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687633 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 78 YR Male