BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 19076638 · Received April 9, 2024

    Report

    Report Number
    2025587-2024-02190
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    December 5, 2023
    Report Date
    April 9, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ONG ET AL. SUCCESSFUL TAVI DESPITE SUDDEN LOW OUTPUT AND VENTRICULAR FIBRILLATION IN A PATIENT WITH CARDIAC AMYLOIDOSIS. C ARDIOVASCULAR INNOVATIONS AND APPLICATIONS. VOL. 8 (2023) 63. ISSN 2009-8618. DOI 10.15212/CVIA.2023.0078. ELECTRONIC PUBLICATION DATE: 05 DECEMBER 2023. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A 79-YEAR-OLD MALE PATIENT WITH SYMPTOMATIC AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A MEDTRONIC 34 MM EVOLUT R BIOPROSTHETIC AORTIC VALVE.  DURING POSITIONING OF THE EVOLUT VALVE THE PATIENT DEVELOPED PROLONGED HYPOTENSION AND SUBSEQUENT LOW CARDIAC OUTPUT REQUIRING CARDIO-PULMONARY RESUSCITATION AND MECHANICAL CIRCULATORY SUPPORT.  VENTRICULAR FIBRILLATION WAS DETECTED WHICH WENT UNRESOLVED DESPITE SEVERAL DEFIBRILLATION ATTEMPTS.  CONSEQUENTLY, THE IMPLANT PROCEDURE CONTINUED UNDER EXTRACORPOREAL LIFE SUPPORT AND ONGOING VENTRICULAR FIBRILLATION.  AFTER SUCCESSFUL VALVE IMPLANTATION VENTRICULAR FIBRILLATION REMAINED UNRESPONSIVE TO DEFIBRILLATION.  WITH ADMINISTRATION OF AMIODARONE AND THEN POTASSIUM, REPEATED DEFIBRILLATION EFFORTS RESULTED IN ASYSTOLE WITH VENTRICULAR PACING SUPPORTED BY TEMPORARY PACEMAKER.  ECHOCARDIOGRAPHY SHOWED IMPAIRED LEFT VENTRICULAR FUNCTION AS WELL AS HIGH-GRADE MITRAL INSUFFICIENCY WHICH WERE IMPROVED WITH ADMINISTRATION OF MILRINONE.  SUBSEQUENTLY STABLE HEMODYNAMICS WERE ACHIEVED ALLOWING FOR REMOVAL FROM EXTRACORPOREAL LIFE SUPPORT AND TRANSFER TO THE INTENSIVE CARE UNIT IN STABLE CONDITION.  THE POST-PROCEDURAL COURSE INCLUDED A PLEURAL PUNCTURE AND INTRAVENOUS DIURETICS DUE TO FLUID RETENTION.  AN ECHOCARDIOGRAPHY SHOWED AN OVERALL ACCEPTABLE RESULT WITH MILD AORTIC REGURGITATION.  AFTER BEING TRANSFERRED TO THE GENERAL WARD, THE PATIENT WAS SUCCESSFULLY DISCHARGED HOME 26 DAYS LATER.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412237 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H| L