BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 25106958 · Received May 6, 2026

    Report

    Report Number
    9617601-2026-02966
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00643169993211
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED, APPROXIMATELY SIX YEARS, NINE MONTHS FOLLOWING THE IMPLANT OF THIS 34MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), MODERATE CENTRAL AORTIC REGURGITATION WAS OBSERVED. UPON EXAMINATION, THE SINOTUBULAR JUNCTION (STJ) HAD A MEAN DIAMETER OF 24MM, WHICH WAS CONSIDERED CONSTRAINED FOR A 34MM DEVICE. CALCIUM BUILDUP WAS IDENTIFIED IN THE PROXIMAL RIGHT CORONARY ARTERY ALONG WITH POSSIBLE PANNUS OR THROMBUS VS. INADEQUATE FILLING SEEN INSIDE THE TAV FRAME. ADDITIONALLY, A POSSIBLE SHORT SEGMENT DISSECTION WAS SEEN IN THE ¿LCI.¿ THE MEAN AREA OF THE VALVE NODES WERE: FROM 3-6, 2-5, AND 1-4, WERE 441 MM2, 457.7 MM2, AND 481.6 MM2 RESPECTIVELY. THE PATIENT WAS EVALUATED TO DETERMINE WHETHER A REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, TAV-IN-TAV, OR A TAV EXPLANT WAS APPROPRIATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182205 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTR-34-C 00643169993211

    Patients

    Seq Age Sex Outcome Treatment
    1