BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 7581064 · Received June 8, 2018

    Report

    Report Number
    2025587-2018-01413
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    January 17, 2018
    Report Date
    June 7, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: POINOT N PULMONARY VALVE REPLACEMENT AFTER RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION WITH HOMOGRAFT VS CONTEGRA®: A CASE CONTROL COMPARISON OF MORTALITY AND MORBIDITY. J CARDIOTHORAC SURG. 2018 JAN 17;13(1):8. DOI: 10.1186/S13019-018-0698-5. 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. 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 PULMONARY VALVE REPLACEMENT AFTER RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION WITH HOMOGRAFT VS CONTEGRA®: A CASE CONTROL COMPARISON OF MORTALITY AND MORBIDITY. ALL DATA WERE COLLECTED FROM SINGLE CENTER BETWEEN JANUARY 1999 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 82 PATIENTS (PREDOMINANTLY MALES), 60 OF WHICH UNDERWENT RIGHT VENTRICLE TO PULMONARY ARTERY CONDUIT PLACEMENTS OR REPLACEMENTS WITH MEDTRONIC CONTEGRA® BOVINE JUGULAR VALVED CONDUIT. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS 2 PATIENTS DIED- ONE DIED DUE TO MASSIVE AIR EMBOLISM OF UNKNOWN ORIGIN THAT OCCURRED DURING CARDIOPULMONARY BYPASS, AND ANOTHER DEATH DUE TO A BIVENTRICULAR CARDIAC FAILURE 31-DAYS POST-SURGERY. BASED ON THE AVAILABLE INFORMATION, NONE OF THESE TWO DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED STENOSIS, REGURGITATION, ENDOCARDITIS, THROMBOSIS AND CALCIFICATION OF CONDUIT, PNEUMOTHORAX, ANEURYSM AND BLEEDING. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426021 VALVE CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention