BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 23526842 · Received November 11, 2025

    Report

    Report Number
    9612164-2025-05568
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    July 15, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AL ADAWI KS, YANG I, HOUBOIS C. LEFT VENTRICULAR WALL PSEUDOANEURYSM POST TRANSCATHETER AORTIC VALVE REPLACEMENT. INT J CA RDIOVASC IMAGING. 2025;41(8):1641-1642. DOI:10.1007/S10554-025-03467-X 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 CASE IN WHICH A LEFT VENTRICULAR (LV) PSEUDOANEURYSM OCCURRED IN A PATIENT AFTER UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A MEDTRONIC 29 MM EVOLUT FX VALVE. THE AUTHORS RECOUNTED THAT THE PATIENT EXPERIENCED TWO SEPARATE INSTANCES OF HEMOPERICARDIUM/PERICARDIAL EFFUSION AFTER VALVE IMPLANT. THE FIRST INSTANCE WAS WITHIN AN HOUR AFTER THE TAVR PROCEDURE (MANIFESTED WITH HYPOTENSION), AND THE SECOND WAS A FEW DAYS AFTER DISCHARGE (MANIFESTED WITH CHEST PAIN AND DYSPNEA). BOTH INSTANCES NECESSITATED PERICARDIOCENTESIS. A SMALL LACERATION OF THE MYOCARDIUM WAS SUSPECTED BY THE AUTHORS BUT WAS NOT CONFIRMED. THE LV PSEUDOANEURYSM WAS IDENTIFIED ON CARDIAC COMPUTED TOMOGRAPHY (CT) DURING THE SECOND HEMOPERICARDIUM OCCURRENCE AND WAS TREATED CONSERVATIVELY WITH SERIAL CT SCANS, WHICH EXHIBITED ¿SPONTANEOUS REGRESSION IN SIZE.¿ THEN THE PATIENT¿S CLINICAL STATUS IMPROVED AND WAS DISCHARGED SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034482 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R