BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 19255967 · Received May 6, 2024

    Report

    Report Number
    2025587-2024-02785
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    June 16, 2022
    Report Date
    May 6, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BERTOGLIO ET AL. SELF-OCCLUDING CANDY-PLUG: IMPLANTATION TECHNIQUE TO OBTAIN FALSE LUMEN THROMBOSIS IN CHRONIC AORTIC DISSECTIONS. J ENDOVASC THER. 2023 DEC;30(6):811-816. DOI: 10.1177/15266028221102661. EPUB 2022 JUN 16. 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 A 69-YEAR-OLD FEMALE PATIENT WHO ONE YEAR PRIOR UNDERWENT IMPLANT OF A MEDTRONIC FREESTYLE AORTIC BIOPROSTHESIS AND A NON-MEDTRONIC GRAFT TO TREAT A TYPE A AORTIC DISSECTION.  ONE YEAR AFTER THE PROCEDURE THE PATIENT HAD PERSISTENT ENLARGEMENT OF AN AORTIC ARCH FALSE LUMEN, AND SUBSEQUENTLY UNDERWENT A FROZEN ELEPHANT TRUNK REPAIR.  LATER, AT A FOLLOW-UP VISIT, A COMPUTED TOMOGRAPHIC ANGIOGRAPHY REVEALED A LARGE FALSE LUMEN ANEURYSM OF THE DESCENDING THORACIC AORTA.  THE PATIENT THEN UNDERWENT ANOTHER PROCEDURE WHERE A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO THE CELIAC TRUNK WAS PERFORMED.  AT THE COMPLETION OF THIS PROCEDURE COMPUTED TOMOGRAPHIC ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED THE FALSE LUMEN WAS CLOSED.  AFTER AN UNEVENTFUL RECOVERY THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY THREE.  AT THE 6-MONTH POSTOPERATIVE CHECK THE PATIENT WAS STABLE WITHOUT SIGNS OF DEVICE MIGRATION OR VISCERAL ARTERIES OCCLUSION.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388064 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R| L