BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 23544252 · Received November 13, 2025

    Report

    Report Number
    9617601-2025-02712
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    June 18, 2025
    Report Date
    November 13, 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
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TONDO ET AL. TRANSCATHETER SELF-EXPANDING VALVE WITH A DUAL PURPOSE - EXCLUSION OF A PSEUDOANEURYSM OF THE MITRAL-AORTIC INTERVALVULAR FIBROSA AND TREATMENT OF AORTIC STENOSIS. CJC OPEN. 2025 JUN 18;7(9):1266¿1270. DOI: 10.1016/J.CJCO.2025.05.019. 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 A 63-YEAR-OLD MALE PATIENT WHO PRESENTED WITH ACUTE CARDIAC AND RESPIRATORY FAILURE DUE TO A PSEUDOANEURYSM OF THE MITRAL-AORTIC INTERVALVULAR FIBROSA. SUBSEQUENTLY, THE PATIENT UNDERWENT A TWO-STEP PROCEDURE WITH IMPLANT A DRUG-ELUTING STENT TO TREAT LEFT CIRCUMFLEX CRITICAL STENOSIS AND IMPLANT OF A MEDTRONIC 29-MM EVOLUT PRO+ BIOPROSTHETIC VALVE FOR AORTIC VALVE STENOSIS. AFTER VALVE RELEASE, THE STENT FRAME WAS NOTED AS UNDER-EXPANDED CAUSING SEVERE AORTIC REGURGITATION (AR). A BALLOON DILATATION REDUCED THE AR FROM SEVERE TO MILD WITH ¿TWO SMALL PARAVALVULAR LEAKS¿. AT THREE MONTHS POST-OPERATIVE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED NORMAL FUNCTION OF THE PROSTHETIC VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195738 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVPROPLUS-29

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R| L