BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT STANDARD AORTIC HEART VALVE

    MDR report key: 15671735 · Received October 26, 2022

    Report

    Report Number
    3008592544-2022-00061
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    January 1, 2022
    Report Date
    October 26, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MANDIYE S.; ET AL. CONSEQUENCES OF MECHANICAL AND BIOPROSTHETIC HEART VALVES REPLACEMENT IN TERTIARY CARE CENTER OF BHOPAL . EUR. J. MOL. CLIN. MED. 2022; 9(3):10169-10175. HTTPS://EJMCM.COM/ARTICLE_18244.HTML EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: ATS MECHANICAL OPEN PIVOT (PMA# P990046, PRODUCT CODE: LWQ); HANCOCK II (PMA# P980043, PRODUCT CODE: DYE). 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 ONE MEDICAL CENTER¿S EXPERIENCE WITH MECHANICAL AND BIOPROSTHETIC HEART VALVE SURGICAL REPLACEMENTS. ALL DATA WERE COLLECTED FROM A SINGLE INDIAN TERTIARY CARE CENTER BETWEEN JANUARY 2018 AND DECEMBER 2021. THE STUDY POPULATION INCLUDED 103 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 39 YEARS. ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC VALVE, WITH 54 PATIENTS RECEIVING AN ATS OPEN PIVOT MECHANICAL VALVE AND 49 PATIENTS RECEIVING A HANCOCK II BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL ATS OPEN PIVOT PATIENTS, THREE DEATHS OCCURRED DUE TO STUCK LEAFLETS FROM VALVE THROMBOSES, RESULTING IN LOW CARDIAC OUTPUT, ACIDOSIS AND EVENTUALLY DEATH, DESPITE USE OF INTRAVENOUS (IV) ANTICOAGULANT AND THROMBOLYTIC AGENTS. BASED ON THE AVAILABLE INFO RMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE DEATHS. AMONG ALL HANCOCK II PATIENTS, TWO DEATHS WERE NOTED, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT ASSOCIATED WITH THESE DEATHS. AMONG ALL ATS OPEN PIVOT PATIENTS, ADVERSE EVENTS INCLUDED: SYSTEMIC THROMBOEMBOLISMS, ANTICOAGULATION-RELATED BLEEDING RESULTING IN SEVERE ANEMIA, MELENA AND EPISTAXIS, WHICH REQUIRED BLOOD PRODUCT TRANSFUSIONS, AND NEED FOR RE-OPERATION DUE TO STUCK MECHANICAL VALVE LEAFLETS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN] ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL HANCOCK II PATIENTS, ADVERSE EVENTS INCLUDED: ONE CASE OF SYSTEMIC THROMBOEMBOLISM. 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
    2573152 OPEN PIVOT STANDARD AORTIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 500FA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention| L