BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7452439 · Received April 23, 2018

    Report

    Report Number
    2025587-2018-00951
    Event Type
    Death
    Date Received
    April 23, 2018
    Date of Event
    May 9, 2017
    Report Date
    April 26, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: JOSEPH KIMMEL, MD. CONVERSION FROM MONITORED ANESTHESIA CARE TO GENERAL ANESTHESIA FOR TRANSCATHETER AORTIC VALVE REPLACEMENT. JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. APRIL 2018; 32(2): PAGES 1032-1040. DOI: 10.1053/J.JVCA.2017.05.015 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISSECTION AND SUBSEQUENT DEATH WERE REPORTEDLY NOT DIRECTLY RELATED TO THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF A (B)(6) FEMALE PATIENT WITH SEVERE AORTIC STENOSIS AND DIASTOLIC HEART FAILURE WHO UNDERWENT IMPLANT OF A 26 MM MEDTRONIC EVOLUTR (SERIAL NUMBER NOT PROVIDED). PERSISTENT EXTRAVASATION WAS NOTED AT THE LEFT SUBCLAVIAN ARTERY AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A TYPE A DISSECTION. THE FAMILY DECLINED FURTHER INTERVENTION AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293771 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death