BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 20413045 · Received October 9, 2024

    Report

    Report Number
    2025587-2024-05615
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    February 3, 2023
    Report Date
    October 9, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HAUNSCHILD ET AL. IS PERIOPERATIVE FAST-TRACK MANAGEMENT THE FUTURE OF PROXIMAL AORTIC REPAIR? EUR J CARDIOTHORAC SURG. 2023 FEB 3;63(2):EZAC578. DOI: 10.1093/EJCTS/EZAC578. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE LWR) AND MOSAIC (PMA# P990064, PRODUCT CODE DYE). 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 PERIOPERATIVE FAST-TRACK MANAGEMENT OF PROXIMAL AORTIC REPAIR. THE UNMATCHED STUDY POPULATION INCLUDED 772 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 59.9 YEARS OLD. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. WITHIN THE PROPENSITY-MATCHED COHORT MEDTRONIC PRODUCTS WERE IMPLANTED IN 198 PATIENTS, WHICH INCLUDED: ATS OPEN PIVOT AORTIC VALVED GRAFT (N=110), FREESTYLE (N=83), MOSAIC (N=4), AND ATS OPEN PIVOT (N=1) BIOPROSTHESES. DEATHS OCCURRED INTHE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: BLEEDING REQUIRING REVISION, STROKE, RENAL FAILURE REQUIRING DIALYSIS, AND POST-OPERATIVE PERCUTANEOUS CORONARY INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916801 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H| L