BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 10752218 · Received October 28, 2020

    Report

    Report Number
    2025587-2020-03288
    Event Type
    Death
    Date Received
    October 28, 2020
    Date of Event
    August 4, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TVT REGISTRY EXEMPTION NUMBER: E2014038 QUARTERLY REPORTING PERIOD: Q3 2020 TOTAL NUMBER OF EVENTS BEING SUMMARIZED: 74 UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED PATIENT DEMOGRAPHICS DETAILS AND LIMITED DETAILS WERE PROVIDED REGARDING THE ADVERSE EVENTS AND OUTCOMES. THE LISTED EVENT DATE IS THE DATE THE INFORMATION WAS RECEIVED BY MEDTRONIC. THE PATIENT INFORMATION INCLUDED IN SECTION A. IS AN AVERAGE OF THE DATA PROVIDED FOR THE EVENTS. A PRODUCT ANALYSIS WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT WAS RETURNED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <(><<)>NOE> 74 <(><<)>/NOE> DEATH EVENTS. THE TYPE OF DEATH REPORTED WAS UNKNOWN. THE AVERAGE TIME TO EVENT WAS TWO HUNDRED TWENTY FOUR DAYS FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT AGES IN THIS REPORT RANGE FROM 47 TO 90 AND OVER. THERE WERE 27 MALES AND 47 FEMALES. THE CAUSE OF DEATH PROVIDED IS LIMITED IN NATURE AS IT IS PROVIDED VIA A THIRD-PARTY DATABASE. MEDTRONIC RECEIVED INFORMATION REGARDING PATIENT/DEVICE EVENTS VIA A THIRD-PARTY POST-IMPLANT DEVICE REGISTRY (THE SOCIETY OF THORACIC SURGEONS/AMERICAN COLLEGE OF CARDIOLOGY TRANSCATHETER VALVE THERAPY REGISTRY). THE INFORMATION IN THIS REPORT WAS PROVIDED TO MEDTRONIC IN A DE-IDENTIFIED FORMAT AND HAS BEEN ORGANIZED INTO SUMMARIES OF OBSERVATIONS RELATED TO PATIENT DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214721 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION COREVALVE EVOLUT PRO & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM)

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death