BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 22031084 · Received May 15, 2025

    Report

    Report Number
    2025587-2025-03714
    Event Type
    Death
    Date Received
    May 15, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 15, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: L-EVOLUTFX-2329 (LOT: 0012347822); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; PRODUCT ID: D-EVOLUTFX-2329 (LOT: 0012370579); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; EXPLANT DATE PRODUCT ID EVFXPLUS-26 (K055267); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025. 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 THAT DURING A TRANSCATHETER VALVE PROCEDURE INVOLVING THE EVFXPLUS-26, FOLLOWING THE PLACEMENT OF THE FIRST VALVE, SEVERE AORTIC INSUFFICIENCY (AI) WAS OBSERVED. IT WAS THOUGHT THAT THE SEVERE AI WAS DUE TO A TORN OR STUCK LEAFLET. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED TO ADDRESS THE AI. DESPITE THE BAV, THE AI DID NOT IMPROVE. A SECOND VALVE WAS IMPLANTED IN THE PATIENT AS CARDIOPULMONARY RESUSCITATION WAS PERFORMED. ULTIMATELY, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897039 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-26

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death