BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT STANDARD AORTIC HEART VALVE

    MDR report key: 21788838 · Received April 7, 2025

    Report

    Report Number
    3008592544-2025-00025
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    June 8, 2024
    Report Date
    April 7, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: TOSHI MAEDA, ET AL. REINTERVENTION AFTER ASCENDING¿DESCENDING AORTIC BYPASS FOR COARCTATION OF THE AORTA IN ADULTHOOD. PROGRESS IN PEDIATRIC CARDIOLOGY. 2024; 74: 101735. DOI.ORG/10.1016/J.PPEDCARD.2024.101735. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER OR (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 A PATIENT WHO UNDERWENT AORTIC VALVE REPLACEMENT USING A MEDTRONIC 20-MM ATS AP 360 MECHANICAL VALVE. IT WAS REPORTED THAT INTRAOPERATIVELY, THE RIGHT CORONARY ARTERY WAS ACCIDENTALLY INJURED, REQUIRING CORONARY ARTERY BYPASS GRAFTING. THE OPERATION TOOK MORE THAN 30 HOURS AND STERNAL CLOSURE WAS IMPOSSIBLE. THE PATIENT EXPERIENCED CARDIAC DYSFUNCTION AND ACUTE KIDNEY INJURY, NECESSITATING THE USE OF MULTIPLE MEDICATIONS AND RENAL REPLACEMENT THERAPY. TWO MONTHS LATER, MEDIASTINITIS DUE TO ESCHERICHIA COLI DEVELOPED. CONCURRENTLY, THERE WAS ONSET OF RIGHT HEART FAILURE ACCOMPANIED BY SEVERE TRICUSPID VALVE REGURGITATION, PREVIOUSLY CLASSIFIED AS MILD PREOPERATIVELY. IT WAS REPORTED THAT 4 MONTHS LATER, THE PATIENT DIED DUE TO HEPATIC FAILURE. THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATH. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001756 OPEN PIVOT STANDARD AORTIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 500FA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention