BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 20528834 · Received October 24, 2024

    Report

    Report Number
    2025587-2024-06012
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 24, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BOUDJEMLINE ET AL. TRANSCATHETER FONTAN COMPLETION: CREATION OF AN EXTRACARDIAC FONTAN. CCI.08JULY2024; (104):264-271. DOI :10.1002/CCD.31131 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. [MEDTRONIC PRODUCTS REFERENCED: CONTEGRA CONDUIT (PMA# H020003, PRODUCT CODE: MWH). 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 A 2 YEAR-OLD MALE PATIENT WEIGHING 10.2KG WHO UNDERWENT TRANSCATHETER FONTAN COMPLETION USING THE CREATION OF AN EXTRACARDIAC FONTAN. A 16MM CONTEGRA CONDUIT WAS IMPLANTED TO REPAIR THE TRICUSPID VALVE THROUGH THE RIGHT ATRIUM IN PREPARATION FOR THE FONTAN PROCEDURE. THE CONTEGRA CONDUIT LEAFLETS WERE CLOSED USING SUTURES, AND THE TOP END OF THE CONDUIT WAS CUT. THE CONTEGRA CONDUIT WAS THEN ANASTOMOSED END TO THE SIDE TO THE RIGHT PULMONARY ARTERY. A LONGITUDINAL INCISION WAS MADE AT THE LATERAL ASPECT OF THE CONTEGRA CONDUIT, BELOW THE VALVE LEAFLETS, TO CREATE A NON-RESTRICTIVE FENESTRATION THAT EQUALED AT LEAST THE DIAMETER OF THE INFERIOR VENA CAVA. STENTS WERE ALSO IMPLANTED DURING THIS PROCEDURE. 10 DAYS POST IMPLANT, THE PATIENT RECEIVED A DUAL CHAMBER EPICARDIAL PACEMAKER DUE TO POST PROCEDURAL COMPLETE HEART BLOCK. SUBSEQUENTLY, 8 MONTHS LATER, THE TRANSCATHETER FONTAN PROCEDURE OCCURRED WITH AN UNKNOWN TRANSCATHETER PRODUCT. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772143 CONTEGRA PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Required Intervention| L| H