BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6150894 · Received December 7, 2016

    Report

    Report Number
    2025587-2016-01939
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    May 3, 2016
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    TITLE: TRANSFEMORAL VALVE-IN-VALVE IMPLANTATION FOR DEGENERATED BIOPROSTHETIC AORTIC VALVES USING THE NEW BALLOON-EXPANDABLE EDWARDS SAPIEN 3 VALVE CITATION: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2016) 88:636¿643 (DOI 10.1002/CCD.26565) AUTHORS: BIRGID GONSKA, MD, JULIA SEEGER, MD, CHRISTOPH RODEWALD, MD, DOMINIK SCHARNBECK, MD, WOLFGANG ROTTBAUER, MD, AND JOCHEN WOHRLE, MD. EARLIEST DATE OF E-PUBLISH/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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE IMPLANT OF TRANSFEMORAL VALVE-IN-VALVE IMPLANTATION USING A NON MEDTRONIC BALLOON EXPANDABLE VALVE. THE STUDY POPULATION INCLUDED NINE PATIENTS (PREDOMINANTLY MALE), 2 OF WHICH WERE IMPLANTED WITH A MEDTRONIC FREESTYLE STENTLESS SURGICAL BIOPROSTHESIS (SERIAL NUMBERS NOT PROVIDED). IT WAS REPORTED THAT A 25MM FREESTYLE STENTLESS SURGICAL BIOPROSTHESIS HAD BEEN IMPLANTED FOR 5 YEARS. THE INDICATION FOR THE VALVE-IN-VALVE PROCEDURE WAS AORTIC STENOSIS WITH PEAK GRADIENT MEASUREMENTS PRIOR TO THE VALVE-IN-VALVE OF 39 MM HG. THE TRANSCATHETER 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
    804277 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR995-25

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention