BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12715251 · Received October 28, 2021

    Report

    Report Number
    2025587-2021-03292
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    June 1, 2002
    Report Date
    October 28, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KANTER K., ET AL. ONE HUNDRED PULMONARY VALVE REPLACEMENTS IN CHILDREN AFTER RELIEF OF RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION. ANN THORAC SURG. 2002 JUNE 01; 73(6):1801-6; DISCUSSION 1806-7. DOI: 10.1016/S0003-4975(02)03568-3. PMID: 12078772. EARLIEST DATE OF PUBLICATION WAS USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE: LWR); HANCOCK (PMA# P870078, PRODUCT CODE: DYE). 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING ONE MEDICAL CENTER¿S EXPERIENCE WITH LATE PULMONARY VALVE REPLACEMENTS FOR CHILDREN WHO PREVIOUSLY UNDERWENT RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) REPAIR. ALL DATA WERE COLLECTED FROM A SINGLE U.S. MEDICAL CENTER BETWEEN FEBRUARY 1989-OCTOBER 2000. THE STUDY POPULATION INCLUDED 93 PEDIATRIC PATIENTS (MEAN AGE 10 YEARS), 19 OF WHOM WERE IMPLANTED WITH MEDTRONIC FREESTYLE PORCINE BIOPROSTHESES AND TWO OF WHOM WERE IMPLANTED WITH MEDTRONIC HANCOCK PORCINE BIOPROSTHESES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL MEDTRONIC FREESTYLE AND HANCOCK PATIENTS, NO DEATHS OCCURRED WITHIN THE STUDY PERIOD. AMONG ALL PATIENTS WHO RECEIVED PORCINE BIOPROSTHESES, ADVERSE EVENTS INCLUDED: MILD-MODERATE PULMONARY STENOSIS AND SIGNIFICANT PULMONARY INSUFFICIENCY, WITH ONE PATIENT REQUIRING RE-DO PULMONARY VALVE REPLACEMENT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612206 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention