BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EVOLUT PRO PLUS VALVE

    MDR report key: 10344366 · Received July 30, 2020

    Report

    Report Number
    2025587-2020-02453
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    June 2, 2020
    Report Date
    January 29, 2021
    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 · 0

    IN ACCORDANCE WITH MODIFICATIONS TO SUMMARY REPORTING REGISTRY EXEMPTION E2014038 RECEIVED ON NOV 9, 2020, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE STS/ACC TVT REGISTRY FOR THE COREVALVE SYSTEM. THE TVT REGISTRY SUBSEQUENTLY REMOVED THE FOLLOWING DATA: ONE VALVE IN VALVE IMPLANT. THE TOTAL EVENTS ARE UPDATED TO 32. UPDATED DATA: H1 NUMBER OF EVENTS (SUMMARY REPORT). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    TVT REGISTRY EXEMPTION NUMBER: E2014038 QUARTERLY REPORTING PERIOD: Q2 2020 TOTAL NUMBER OF EVENTS BEING SUMMARIZED: 33 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. 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 · 0

    THIS REPORT SUMMARIZES <(><<)>NOE> 33 <(><<)>/NOE> SERIOUS INJURY EVENTS. THE TYPE OF SERIOUS INJURIES REPORTED WERE VALVE IN VALVE IMPLANTS. THE AVERAGE TIME TO EVENT WAS ZERO DAYS FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT AGES IN THIS REPORT RANGE FROM 69 TO 90 AND OVER. THERE WERE 20 MALES AND 13 FEMALES. THE TYPE OF SERIOUS INJURY INFORMATION 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 SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811826 EVOLUT PRO PLUS 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 78 YR Required Intervention