BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 5259735 · Received December 1, 2015

    Report

    Report Number
    2025587-2015-01262
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    December 29, 2014
    Report Date
    November 12, 2015
    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

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A DIRECT FLOW MEDICAL VALVE IN A PATIENT WITH SEVERE AORTIC REGURGITATION DUE TO DEGENERATED AORTIC STENTLESS BIOPROSTHESIS CITATION: INTERNATIONAL JOURNAL OF CARDIOLOGY 182 (2015) 267¿270 AUTHORS: VASILEIOS F. PANOULAS, AZEEM LATIB, ANTONIO COLOMBO DATE OF E-PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW THAT A PATIENT UNDERWENT A PROCEDURE TO IMPLANT A MEDTRONIC 23-MM STENTLESS AORTIC ROOT BIOPROSTHESIS (SERIAL NUMBER NOT PROVIDED) IN THE YEAR 2000. THE PATIENT'S MEDICAL HISTORY ALSO INCLUDED HYPERTENSION, HYPERCHOLESTEROLEMIA, CORONARY ARTERY BYPASS SURGERY, CAROTID ENDARTERECTOMY, AND FEMORO-FEMORAL CROSSOVER BYPASS DUE TO OCCLUDED LEFT COMMON ILIAC ARTERY. IN AN UNREPORTED POST-IMPLANT TIME FRAME (HOWEVER LIKELY SEVERAL YEARS POST-IMPLANT), THE BIOPROSTHESIS WAS NOTED AS DEGENERATED WITH RETRACTION OF THE NON-CORONARY CUSP AND PROLAPSE OF THE RIGHT CORONARY CUSP RESULTING IN SEVERE AORTIC REGURGITATION. THE (B)(6) FEMALE PATIENT THEN UNDERWENT AN INTERVENTION IN WHICH A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787260 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995CS23

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention