BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING TRI-AD 900SFC26

    MDR report key: 21845281 · Received April 15, 2025

    Report

    Report Number
    2025587-2025-02696
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    April 22, 2024
    Report Date
    April 15, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K093903
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AUTHORS: KIM ET AL.. EARLY AND MID-TERM OUTCOMES OF TRICUSPID VALVE SURGERY IN PATIENTS WITH FUNCTIONAL TRICUSPID REGURGITATION INDUCED BY ATRIAL FIBRILLATION. JOURNAL OF THORACIC DISEASE 16(4) 2394-2403 2024. 10.21037/JTD-23-1776 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 EARLY AND MID-TERM OUTCOMES OF TRICUSPID VALVE SURGERY IN PATIENTS WITH FUNCTIONAL TRICUSPID REGURGITATION INDUCED BY ATRIAL FIBRILLATION. THE STUDY POPULATION INCLUDED 43 PATIENTS WITH A MEAN AGE OF 69 YEARS WHO WERE PREDOMINANTLY FEMALE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; IT IS UNKNOWN HOW MANY PATIENTS WERE IMPLANTED WIT H A MEDTRONIC TRI-AD ANNULOPLASTY DEVICE. 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 PATIENTS ADVERSE EVENTS INCLUDED: CONCOMITANT MAZE PROCEDURE, FULL TRICUSPID VALVE REPLACEMENT, LOW CARDIAC OUTPUT, BLEEDING NECESSITATING RE-OPERATION, ACUTE KIDNEY INJURY (AKI), STROKE, RESPIRATORY COMPLICATION, PACEMAKER IMPLANT, ATRIAL FIBRILLATION, RE-OPERATION, MODERATE TO SEVERE TRICUSPID REGURGITATION AND HEART FAILURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350851 RING TRI-AD 900SFC26 RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 900SFC26

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| H| L