BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 23020766 · Received September 10, 2025

    Report

    Report Number
    2025587-2025-05640
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    December 2, 2023
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 A META-ANALYSIS OF VALVED CONDUITS FOR RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION: A REVIEW OF CURRENT TECHNOLOGIES AND FUTURE DIRECTIONS. MULTIPLE MANUFACTURER¿S DEVICES WERE REFERENCED; MEDTRONIC DEVICES REFERENCED INCLUDED CONTEGRA CONDUIT AND HANCOCK VALVED CONDUIT. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS THAT MAY HAVE OCCURRED IN ASSOCIATION WITH AMEDTRONIC DEVICE INCLUDED: INFECTIVE ENDOCARDITIS, DISTAL STENOSIS, STRUCTURAL VALVE DEGENERATION, REGURGITATION, CONDUIT COMPRESSION, DILATION, RE-INTERVENTION, EXPLANT AND IMMUNOGENIC REACTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062361 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L