BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 23000101 · Received September 9, 2025

    Report

    Report Number
    2025587-2025-05618
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 28, 2024
    Report Date
    September 8, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BAJOREK ET AL.. COMPARISON OF FOUR AORTIC BIOPROSTHESES: HANCOCK II VS. ST JUDE TRIFECTA VS. CARPENTIER-EDWARDS PERIMOUNT MAGNA VS. MAGNA EASE¿MID-TERM RESULTS (COMPARE SAVR STUDY). JOURNAL OF THORACIC DISEASE 16(8) 2024. 10.21037/JTD-22-1761 EARLIEST DATE OF PUBLICATION 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING COMPARISON OF FOUR AORTIC BIOPROSTHESES: HANCOCK II VS. ST JUDE TRIFECTA VS. CARPENTIER-EDWARDS PE RIMOUNT MAGNA VS. MAGNA EASE¿MID-TERM RESULTS (COMPARE SAVR STUDY). THE STUDY POPULATION INCLUDED 1589 PATIENTS WITH A MEAN AGE OF 69 YEARS WHO WERE PREDOMINANTLY MALE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; / 432 PATIENTS WHO WERE PREDOMINANTLY MALE WERE IMPLANTED WITH A MEDTRONIC HANCOCK II AORTIC BIOPROSTHETIC VALVE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL MEDTRONIC HANCOCK II AORTIC BIOPROSTHETIC VALVE PATIENTS, ADVERSE EVENTS INCLUDED: HIGH MEAN AND MAXIMUM GRADIENTS AND LONGER EXTRACORPOREAL CIRCULATION TIME. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258462 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization