BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6693556 · Received July 7, 2017

    Report

    Report Number
    2025587-2017-01120
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 2, 2016
    Report Date
    June 15, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MOHINEESH KUMAR, MD ARTICLE TITLE. RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION WITH A POLYTETRAFLUOROETHYLENE MONOCUSP VALVE: A 20-YEAR EXPERIENCE JOURNAL TITLE. SEMIN THORAC CARDIOVASC SURG PUBLISH DATE: 2016: 28(2):463-470 10.1053/J.SEMTCVS.2016.05.003 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. SEPARATE MEDWATCH REPORTS ARE FILED FOR EACH OF THE VALVES LISTED.

    Additional Manufacturer Narrative · 1

    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 PATIENTS WITH TETRALOGY OF FALLOT (TOF), PULMONARY ATRESIA (PA), AND OTHER CONGENITAL RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) MALFORMATIONS, USING POLYTETRAFLUOROETHYLENE (PTFE) MONOCUSP OUTFLOW TRACT PATCHES (MOTP) TO RELIEVE OBSTRUCTION AND PROVIDE PULMONARY VALVE COMPETENCE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1994-2014. THE STUDY POPULATION INCLUDED 171 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 1.5 YEARS), 21 OF WHICH WERE IMPLANTED WITH MEDTRONIC CONTEGRA, 5 WERE IMPLANTED WITH A MEDTRONIC FREESTYLE, 4 WERE IMPLANTED WITH A MEDTRONIC MELODY AND 2 WERE IMPLANTED WITH A MEDTRONIC MOSAIC (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS' ADVERSE EVENTS INCLUDED: ARRHYTHMIAS, LOW CARDIAC OUTPUT, BOWELISCHEMIA, PLEURAL EFFUSION, REOPERATION, MODERATE OR SEVERE TRICUSPID REGURGITATION, SEVERE PULMONARY STENOSIS OR SEVERE PULMONARY REGURGITATION, DILATED RIGHT VENTRICLE (RV), RV DYSFUNCTION AND FAILURE, PULMONARY STENOSIS, ENDOCARDITIS, RESIDUAL VENTRICULAR SEPTAL DEFECT (VSD), PSEUDOANEURYSM, SUPRAVALVULAR OR SUBVALVULAR STENOSIS, OUTGROWTH AND COMPLETE HEART BLOCK (CHB) WITH PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473685 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR995-19

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention