BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPEN PIVOT STANDARD AORTIC HEART VALVE

    MDR report key: 21118511 · Received January 9, 2025

    Report

    Report Number
    3008592544-2025-00005
    Event Type
    Death
    Date Received
    January 9, 2025
    Date of Event
    August 21, 2024
    Report Date
    January 9, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AUTHORS: ANDREEVA ET AL.. DECELLULARIZED AORTIC HOMOGRAFTS VERSUS MECHANICAL COMPOSITE GRAFTS FOR AORTIC ROOT REPLACEMENT. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 66(2) 2024. 10.1093/EJCTS/EZAE314 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: OPEN PIVOT MECHANICAL HEART VALVE (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 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 DECELLULARIZED AORTIC HOMOGRAFTS VERSUS MECHANICAL FOR AORTIC ROOT REPLACEMENT. THE STUDY POPULATION INCLUDED 289 PATIENTS WITH A MEAN AGE OF 48 YEARS WHO WERE PREDOMINANTLY MALE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 216 PATIENTS WERE IMPLANTED WITH A MEDTRONIC OPEN PIVOT AORTIC MECHANICAL VALVE. PATIENT DEATHS OCCURRED IN THE STUDY POPULATION; THE CAUSES OF DEATH WERE FULMINANT SEPSIS, INTRACRANIAL HEMORRHAGE, PERICARDIAL EFFUSION AND MULTIORGAN FAILURE WITH MYOCARDIAL INFARCTION OF THE ANTEROLATERAL PAPILLARY MUSCLE. AMONG OPEN PIVOT AORTIC MECHANICAL VALVE PATIENTS, ADVERSE EVENTS INCLUDED: BLEEDING (CEREBRAL AND PERIPHERAL), VALVE THROMBOSIS, CEREBRAL EMBOLISM, STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), ENDOCARDITIS, PACEMAKER IMPLANT, AORTIC ROOT DISSECTION, PSEUDOANEURYSM AND RE-INTERVENTION OR REPLACEMENT.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324655 OPEN PIVOT STANDARD AORTIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 500FA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Life Threatening| H| D| R