BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 15414441 · Received September 13, 2022

    Report

    Report Number
    2025587-2022-02530
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    March 11, 2022
    Report Date
    September 13, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MONNIN C, ET AL. PREVALENCE AND SEVERITY OF COGNITIVE DYSFUNCTION IN PATIENTS REFERRED FOR TRANSCATHETER AORTIC VALVE IMPL ANTATION (TAVI): CLINICAL AND COGNITIVE IMPACT AT 1 YEAR. AGING CLINICAL AND EXPERIMENTAL RESEARCH. 2022 AUG;34(8):1873-1883. DOI: 10.1007/S40520-022-02102-2. EPUB 2022 MAR 11. 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. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE PREVALENCE AND SEVERITY OF COGNITIVE DYSFUNCTION IN PATIENTS REFERRED FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND THE IMPACT AT ONE-YEAR POST-IMPLANT. ALL DATA WAS COLLECTED FROM ASINGLE CENTER BETWEEN JUNE 2019 AND OCTOBER 2020. A TOTAL OF 84 PATIENTS WERE INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEDIAN AGE 85 YEARS). PATIENTS UNDERWENT TAVI WITH EITHER A NON-MEDTRONIC VALVE TYPE (N = 53) OR A MEDTRONIC COREVALVE (N = 31). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL 84 PATIENTS, 4 DEATHS OCCURRED WITHIN ONE YEAR OF TAVI. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN COREVALVE AND THE DEATHS. AMONG ALL 84 PATIENTS, THE FOLLOWING NON-DEATH ADVERSE EVENTS OCCURRED BETWEEN THE IN-HOSPITAL COURSE AND ONE-YEAR FOLLOW-UP: TAMPONADE REQUIRING PERCUTANEOUS DRAIN AND TRANSFUSION, PERMANENT PACEMAKER IMPLANTATION, VASCULAR COMPLICATIONS, BLEEDING COMPLICATIONS, STROKE, WORSENED COGNITIVE FUNCTION, UNSCHEDULED HOSPITAL READMISSION, HEART FAILURE SYMPTOMS, AND ELEVATED MEAN TRANSVALVULAR GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390888 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Life Threatening| S| R| H