BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 22012540 · Received May 13, 2025

    Report

    Report Number
    2025587-2025-03633
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 2, 2025
    Report Date
    May 13, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: WILLIAM DAVALAN ET AL. ACUTE IATROGENIC AORTIC ROOT DISSECTION WITH PSEUDOANEURYSM AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. JACC CASE REP. APR 2;30(7):103376. 2025. 10.1016/J.JACCAS.2025.103376. 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 PATIENT WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT WITH IMPLANT OF A MEDTRONIC 29-MM EVOLUT FX BIOPROSTHETIC VALVE. FOLLOWING SUCCESSFUL VALVE DEPLOYMENT, A COMPUTED TOMOGRAPHY REVEALED AN AORTIC ROOT DISSECTION OF THE NONCORONARY SINUS OF VALSALVA AND ACUTE MEDIASTINAL HEMATOMA SURROUNDING THE AORTIC ROOT. AS THE MEDICAL TEAM DEEMED THE PATIENT NOT SUITABLE FOR SURGERY DUE TO EXTENSIVE AORTIC CALCIFICATIONS, TREATMENT CONTINUED WITH PRESCRIBED MEDICATION. DESPITE THE PRESENCE OF AN AORTIC DISSECTION AND MEDIASTINAL HEMATOMA, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AFTER THE PROCEDURE. AT ONE DAY POST-PROCEDURE A TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED A MILD PARAVALVULAR LEAK. ON DAY TWO POST-PROCEDURE A COMPUTED TOMOGRAPHY SHOWED A WELL-DEFINED PSEUDOANEURYSM WITH A SURROUNDING HEMATOMA AND ACUTE THROMBUS. ADDITIONALLY, A NEW-ONSET LEFT BUNDLE BRANCH BLOCK AND SLOW-RATE ATRIAL FIBRILLATION REQUIRED IMPLANT OF A PERMANENT PACEMAKER. ON DAY FOUR POST-PROCEDURE A COMPUTED TOMOGRAPHY CONFIRMED A DECREASE IN THE SIZE OF THE PSEUDOANEURYSM AND ASSOCIATED HEMATOMA, AND THE PATIENT WAS DEEMED TO BE STABLE FOR DISCHARGE. SEVEN DAYS AFTER DISCHARGE, AT THE FIRST OUTPATIENT FOLLOW-UP, THERE WAS COMPLETE BLOOD CLOT FORMATION OF THE AORTIC DISSECTION¿S FALSE LUMEN. AT TWO MONTHS POST-PROCEDURE, THE PATIENT HAD COMPLETE RESOLUTION OF THE FOCAL DISSECTION FLAP WITH NO EVIDENCE OF ONGOING AORTIC DISSECTION. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356933 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-29

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H