BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 14578890 · Received June 2, 2022

    Report

    Report Number
    2025587-2022-01546
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    November 1, 2004
    Report Date
    June 2, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KAMEDA, Y. ET AL. AORTOPULMONARY FISTULA DUE TO PERFORATION OF THE AORTIC WALL OF A FREESTYLE STENTLESS VALVE. THE ANNALS OF THORACIC SURGERY. 2004. 78:1827-1829. DOI:10.1016/J.ATHORACSUR.2003.07.025 EARLIEST DATE OF PUBLISH 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A FEMALE PATIENT WITH AN AORTIC ANEURYSM AND SEVERE AORTIC REGURGITATION WHO UNDERWENT THE IMPLANT OF A 23MM MEDTRONIC FREESTYLE AORTIC ROOT. NO SERIAL NUMBERS WERE PROVIDED. APPROXIMATELY FIFTEEN MONTHS AFTER THE IMPLANT, AT AGE (B)(6), A COMPUTED TOMOGRAPHY (CT) INDICATED A PARA-AORTIC HEMATOMA WITH CONTRAST LEAKAGE FROM THE ASCENDING AORTIC PROSTHESIS. SURGERY WAS PERFORMED TO REPAIR THE FREESTYLE WITH A GRAFT AND TO REPLACE THE MITRAL VALVE. PER THE AUTHORS, IT WAS SUSPECTED THAT THE FREESTYLE MAY HAVE BEEN DAMAGED BY FORCEPS DURING THE IMPLANT OPERATION AND SLOWLY RESULTED IN WALL RUPTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198042 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R