BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 6855581 · Received September 11, 2017

    Report

    Report Number
    2025587-2017-01578
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    August 12, 2015
    Report Date
    August 21, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SHINKAWA T ET AL. THE MIDTERM OUTCOMES OF BIOPROSTHETIC PULMONARY VALVE REPLACEMENT IN CHILDREN. SEMINARS IN THORACIC AND CARDIOVASCULAR SURGERY. 2015. 27(3):310-8 DOI: 10.1053/J.SEMTCVS.2015.07.010 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. 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 REGARDING A RETROSPECTIVE REVIEW OF OUTCOMES OF BIOPROSTHETIC PULMONARY VALVE REPLACEMENT IN CHILDREN. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1992 AND 2013. THE STUDY POPULATION INCLUDED 123 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 13 YEARS), 15 OF WHICH WERE IMPLANTED WITH MEDTRONIC HANCOCK II (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE INSUFFICIENCY, ELEVATED PEAK GRADIENT, ENDOCARDITIS, AND STENOSIS REQUIRING REOPERATION OR CATHETER-BASED INTERVENTION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636324 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention