BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 15383961 · Received September 8, 2022

    Report

    Report Number
    2025587-2022-02485
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    March 2, 2021
    Report Date
    September 8, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HU X.; ET AL. PROSTHESIS SELECTION FOR AORTIC VALVE REPLACEMENT WITH CONCOMITANT CORONARY ARTERY BYPASS GRAFTING. ANN THORAC SURG. 2022 JAN;113(1):100-108. DOI: 10.1016/J.ATHORACSUR.2021.02.033. PMID: 33667456. EPUB 2021 MAR 2 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PMA# P980042, PRODUCT CODE: DYE); ATS MECHANICAL VALVE [OPEN PIVOT] (PMA# P990046, PRODUCT CODE: LWQ). 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 LONG-TERM OUTCOMES AFTER PATIENTS UNDERWENT CONCOMITANT CORONARY ARTERY BYPASS GRAFT (CABG) AND AORTIC VALVE REPLACEMENT SURGERY (SAVR). ALL DATA WERE COLLECTED FROM MULTIPLE HUBEI PROVINCE, CHINA HOSPITALS BETWEEN JANUARY 2001 AND DECEMBER 2018. THE STUDY POPULATION INCLUDED 2,485 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 62 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 533 PATIENTS WERE IMPLANTED WITH A MEDTRONIC HANCOCK II AORTIC BIOPROSTHESIS AND 1,952 PATIENTS WERE IMPLANTED WITH A MECHANICAL AORTIC VALVE, WITH AN UNDETERMINED NUMBER RECEIVING AN ATS OPEN PIVOT VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 98 DEATHS OCCURRED, WITH 57 CARDIAC-RELATED DEATHS OVER A 15-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. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKES, INTRACEREBRAL BLEEDS, GASTROINTESTINAL BLEEDING (GIB), HEMOPTYSIS AND RE-HOSPITALIZATION FOR AORTIC VALVE REPLACEMENT RE-OPERATIONS FOR FAILED/DYSFUNCTIONAL AORTIC PROSTHESES. 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
    2237352 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| L| R