BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 11838125 · Received May 17, 2021

    Report

    Report Number
    2025587-2021-01561
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 17, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FEISTRITZER HJ, ET AL. IMPACT OF ANESTHESIA STRATEGY AND VALVE TYPE ON CLINICAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. J AM COLL CARDIOL. 2021 MAY 4;77(17):2204-2215. DOI: 10.1016/J.JACC.2021.03.007. AVAILABLE ONLINE (B)(6) 2021. EARLIEST DATE OF PUBLISH 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE EFFECT OF SECOND GENERATION TRANSCATHETER VALVES (EVOLUT R VERSUS SAPIEN 3) AND ANESTHESIA STRATEGY (CONSCIOUS SEDATION VERSUS GENERAL ANESTHESIA) ON PATIENT OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM SEVEN GERMAN CENTERS BETWEEN APRIL 2016 AND APRIL 2018. THE STUDY POPULATION INCLUDED 438 PATIENTS. OF THOSE, 219 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81.7 YEARS) UNDERWENT TAVR WITH THE MEDTRONIC EVOLUT R. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R PATIENTS, A TOTAL OF 36 DEATHS (34 ALL-CAUSE, 2 CARDIOVASCULAR) OCCURRED WITHIN ONE-YEAR AFTER TAVR. NONE OF THE DEATHS WERE DIRECTLY ATTRIBUTED TO EVOLUT R. AMONG ALL EVOLUT R PATIENTS, ADVERSE EVENTS THAT OCCURRED WITHIN ONE-YEAR AFTER TAVR INCLUDED: PERMANENT PACEMAKER IMPLANTATION, DISABLING ISCHEMIC STROKE, AND MODERATE TO SEVERE PARAVALVULAR LEAK. ADVERSE EVENTS THAT MAY HAVE OCCURRED IN EVOLUT R PATIENTS WITHIN ONE-YEAR AFTER TAVR: MYOCARDIAL INFARCTION AND INFECTIONS REQUIRING ANTIBIOTICS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728319 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R| S