BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 12322682 · Received August 16, 2021

    Report

    Report Number
    2025587-2021-02553
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 16, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SUBAHI A., ET AL. BALLOON EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION IN FAILING SELF-EXPANDABLE TRANSCATHETER VALVE IN DEGENERATED SURGICAL BIOPROSTHESIS: VALVE-IN-VALVE-IN-VALVE IMPLANTATION FOR THE TREATMENT OF EARLY DEGENERATIVE PROSTHETIC INSUFFICIENCY. OSCHNER J., 2021 SUMMER; 21(2):205-208. PUBLISHED ONLINE JUNE 2021. PMID: (B)(4). DOI: 10.31486/TOJ.20.0011 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE: LWR); COREVALVE (PMA# P130021, PRODUCT CODE: NPT). 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. 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 (B)(6)-YEAR-OLD MALE PATIENT WITH HYPERTENSION, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE, ISCHEMIC CARDIOMYOPATHY, A HISTORY OF TRIPLE CORONARY ARTERY BYPASS SURGERY IN 2004, ASCENDING AORTIC ANEURYSM REPAIR AND AORTIC VALVE REPLACEMENT FOR SEVERE AORTIC STENOSIS IN 2012 USING A 29-MM MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). IN 2015, THE PATIENT DEVELOPED ACUTE SEVERE AORTIC REGURGITATION FROM A TEAR IN THE FREESTYLE LEFT CUSP. THE PATIENT UNDERWENT TRANSCATHETER VALVE-IN-VALVE (VIV) IMPLANTATION OF A 29-MM MEDTRONIC COREVALVE BIOPROSTHESIS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). IN 2019, THE PATIENT WAS HOSPITALIZED WITH ACUTE SEVERE HEART FAILURE AND PULMONARY EDEMA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED HIGH TRANSVALVULAR GRADIENTS, SEVERE CENTRAL AORTIC REGURGITATION, SECONDARY SEVERE MITRAL REGURGITATION AND PULMONARY HYPERTENSION. THE PATIENT UNDERWENT TRANSCATHETER AORTIC VALVE-IN-VALVE-IN-VALVE REPLACEMENT WITH A NON-MEDTRONIC BIOPROSTHESIS AND WAS LATER DISCHARGED FROM THE HOSPITAL WITH IMPROVED SYMPTOMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225847 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R VASCUTEK TERUMO AORTIC BIOPROSTHESIS.