BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTEGRA

    MDR report key: 16283517 · Received February 2, 2023

    Report

    Report Number
    2025587-2023-00371
    Event Type
    Death
    Date Received
    February 2, 2023
    Date of Event
    September 7, 2022
    Report Date
    February 2, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: WANG X.; ET AL. OUTCOMES AFTER RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION WITH VALVE SUBSTITUTES: A SYSTEMATIC REVIEW AND META-ANALYSIS. FRONT CARDIOVASC MED. 2022 SEP 7;9:897946. DOI: 10.3389/FCVM.2022.897946. ECOLLECTION 2022. PMID: 36158811. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (PMA# H020003, PRODUCT CODE: MWH); FREESTYLE (PMA# P970031, PRODUCT CODE: LWR). 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 OUTCOMES OF RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) RECONSTRUCTION USING VARIOUS VALVE SUBSTITUTES. ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF ARTICLES PUBLISHED BETWEEN JANUARY 2000 AND JUNE 2021. THE STUDY POPULATION INCLUDED 37,078 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 23 YEARS ACROSS 217 ARTICLES MAKING UP THE META-ANALYSIS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; APPROXIMATELY 2582 PATIENTS WERE IMPLANTED WITH A MEDTRONIC CONTEGRA VALVED CONDUIT AND APPROXIMATELY 703 WERE IMPLANTED WITH A MEDTRONIC FREESTYLE BIOPROSTHESIS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, EARLY VALVE-RELATED MORTALITY (OPERATIVE OR IN-HOSPITAL) WAS 0.74% OF PATIENTS AND LATE VALVE-RELATED MORTALITY (AFTER 30-DAYS OR POST-HOSPITAL DISCHARGE) WAS 0.25% OF PATIENTS IN THE META-ANALYSIS.NO FURTHER DETAILS WERE PROVIDED ON THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: BLEEDING REQUIRING SURGICAL RE-EXPLORATION; VENTRICULAR TACHYCARDIA (VT); CONDUCTION ABNORMALITIES REQUIRING PERMANENT PACEMAKER OR DEFIBRILLATOR IMPLANTATION; STROKES; THROMBOEMBOLISMS; MYOCARDIAL INFARCTIONS (MI); ENDOCARDITIS; VALVULAR DYSFUNCTION LEADING TO PULMONARY STENOSIS/REGURGITATION REQUIRING VALVE REPLACEMENTS. 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
    846401 CONTEGRA PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Death