BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRUCTURAL HEART PRODUCT

    MDR report key: 5292002 · Received December 12, 2015

    Report

    Report Number
    2025587-2015-01318
    Event Type
    Injury
    Date Received
    December 12, 2015
    Date of Event
    October 1, 2014
    Report Date
    November 12, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: SURGICAL PULMONARY VALVE REPLACEMENT: A BENCHMARK FOR OUTCOMES COMPARISONS CITATION: J THORAC CARDIOVASC SURG 2014;148:1450-3 AUTHORS: E. DEAN MCKENZIE, MD, MUHAMMAD S. KHAN, MD, THOMAS W. DIETZMAN, BS, ET AL. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4).

    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 REVIEW THAT A RETROSPECTIVE STUDY (JULY 1995 TO DECEMBER 2010) WAS PERFORMED TO EVALUATE OUTCOMES OF PULMONARY VALVE/CONDUIT REPLACEMENT (PVR) AT A LARGE PEDIATRIC HOSPITAL TO PROVIDE CONTEMPORARY BENCHMARK DATA FOR COMPARISON WITH DEVELOPING TECHNOLOGIES. THE STUDY POPULATION INCLUDED 148 PATIENTS (PREDOMINANTLY MALE, MEDIAN AGE OF 15.9 YEARS, MEDIAN WEIGHT 55.3 GK), 52 OF WHICH WERE IMPLANTED WITH A MEDTRONIC BIOPROSTHESIS (THREE PRODUCT FAMILIES, SERIAL NUMBERS NOT PROVIDED). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE, HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE BETWEEN EVENTS AND PRODUCT. AMONG ALL PATIENTS TWO DEATHS OCCURRED ON FOLLOW-UP AFTER 2 YEARS POST-IMPLANT (CAUSES OF DEATH WERE SECONDARY TO SEVERE CARDIAC DYSFUNCTION AND A RESPIRATORY TRACT INFECTION LEADING TO RESPIRATORY FAILURE); NEITHER DEATH WAS ATTRIBUTED TO MEDTRONIC PRODUCT. ONE NOTED ADVERSE EVENT INCLUDED AN INTERVENTION SECONDARY TO MEDIASTINAL HEMATOMA IN WHICH NO ACTIVE BLEEDING WAS IDENTIFIED. ADDITIONALLY, OTHER INTERVENTIONS OCCURRED, NOTED AS FREEDOM FROM PULMONARY VALVE RE-INTERVENTION AT 1, 3, AND 5 YEARS WAS 99%, 99%, AND 94% RESPECTIVELY, HOWEVER NO OTHER DETAILS WERE PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821302 STRUCTURAL HEART PRODUCT LWR MEDTRONIC HEART VALVES DIVISION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization| R