BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 14994121 · Received July 12, 2022

    Report

    Report Number
    2025587-2022-01907
    Event Type
    Death
    Date Received
    July 12, 2022
    Date of Event
    February 25, 2022
    Report Date
    July 12, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HAOUZI A.; ET AL. CLINICAL MANAGEMENT OF CONDUCTION ABNORMALITIES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT: PROSPE CTIVE EVALUATION OF A STANDARDIZED MANAGEMENT PATHWAY. J INTERV CARD ELECTROPHYSIOL. 2022; 64(1): 195¿202. DOI: 10.1007/S10840-022-01156-6. PMID: 35212830. PUBLISHED ONLINE 2022 FEB 25. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT PRO+ (PMA# P130021, PRODUCT CODE: NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A CLINICAL MANAGEMENT PATHWAY FOR CARDIAC CONDUCTION ABNORMALITIES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE PROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2020 AND FEBRUARY 2021. THE STUDY POPULATION INCLUDED 181 PATIENTS WITHOUT PRIOR PACEMAKER IMPLANTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 78 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, 45 WERE IMPLANTED WITH MEDTRONIC EVOLUT PRO+ BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, SEVEN DEATHS OCCURRED BY ONE-MONTH POST-TAVR. IT WAS NOTED THE DEATHS WERE NOT DUE TO SYNCOPE, CARDIAC CONDUCTION ABNORMALITIES NOR NEED FOR PACEMAKER IMPLANTATION, BUT DUE TO POST-TAVR-RELATED VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG TWO PATIENTS WHO RECEIVED MEDTRONIC EVOLUT PRO+ BIOPROSTHETIC VALVES, ADVERSE EVENTS INCLUDED: COMPLETE HEART BLOCK DURING TAVR REQUIRING IMMEDIATE PERMANENT PACEMAKER IMPLANTATION (PPMI). BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652003 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-23US

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death| L| R