BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 10054132 · Received May 13, 2020

    Report

    Report Number
    2025587-2020-01624
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 13, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ALI BG. SUCCESSFUL IMPLANTATION OF SELF-EXPANDING VALVE FOR A FAILED STENTLESS PROSTHESIS. JOURNAL OF CARDIAC SURGERY. 2020. DOI: 10.1111/JOCS.14520. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A 77-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF SEVERE AORTIC STENOSIS, ENDOCARDITIS, GASTRIC HEMORRHAGE, AND CEREBRAL VASCULAR ACCIDENT WHO UNDERWENT IMPLANT OF A 23MM MEDTRONIC FREESTYLE BIOPROSTHETIC ROOT REPLACEMENT 11 YEARS PRIOR. NO SERIAL NUMBERS WERE PROVIDED. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, A 15% EJECTION FRACTION, AND SEVERE PULMONARY HYPERTENSION SECONDARY TO SEVERE AORTIC INSUFFICIENCY. A 29MM MEDTRONIC EVOLUT R TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. FOLLOWING THE IMPLANT OF THE TRANSCATHETER VALVE, MILD CENTRAL REGURGITATION AND A MILD PARAVALVULAR LEAK WERE OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516024 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention