BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 15459510 · Received September 20, 2022

    Report

    Report Number
    2025587-2022-02601
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    October 20, 2019
    Report Date
    September 20, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HEIDARI ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT OUTCOMES IN PATIENTS WITH SARCOPENIA. EUROINTERVENTION. 2019 OCT 20 ;15(8):671-677. DOI: 10.4244/EIJ-D-19-00110. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R. 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. 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 VIA LITERATURE REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) OUTCOMES IN PATIENTS WITH SARCOPENIA. ALL DATA WERE COLLECTED RETROSPECTIVELY FROM A SINGLE CENTER BETWEEN FEBRUARY 2012 AND JUNE 2016. THE STUDY POPULATION INCLUDED 602 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 80.9 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; AN UNSPECIFIED NUMBER OF PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS THERE WERE 7 IN-HOSPITAL DEATHS, 3 DEATHS WITHIN 30 DAYS, AND 165 DEATHS DURING THE 4-YEAR FOLLOW-UP PERIOD. NO FURTHER DETAILS WERE PROVIDED ON THE DEATHS. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CARDIAC ARREST, STROKE, TRANSIENT ISCHEMIC ATTACK, MYOCARDIAL INFARCTION, LIFE-THREATENING BLEEDING EVENTS, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, ATRIAL FIBRILLATION, AND MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). 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
    1435835 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Hospitalization| L| R