BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 11066996 · Received December 23, 2020

    Report

    Report Number
    2025587-2020-03935
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    January 1, 2011
    Report Date
    December 23, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DAVE, H. ET AL. RISK FACTOR ANALYSIS OF 170 SINGLE-INSTITUTIONAL CONTEGRA IMPLANTATIONS IN PULMONARY POSITION. ANN THORAC SURG 2011;91:195¿203. DOI: 10.1016/J.ATHORACSUR.2010.07.058. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA PULMONARY VALVED CONDUIT (PMA# H020003, PRODUCT CODE MWH). 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING RISK FACTOR ANALYSIS OF CONTEGRA IMPLANTATIONS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2001 AND 2007. THE STUDY POPULATION INCLUDED 170 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 9 YEARS), ALL OF WHOM WERE IMPLANTED WITH MEDTRONIC CONTEGRA VALVED CONDUIT. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL CONTEGRA PATIENTS, ADVERSE EVENTS INCLUDED: STENOSIS, INCREASED GRADIENT MEASUREMENTS, SEVERE REGURGITATION, CALCIFICATION, OUTGROWTH, ANEURYSM, ENDOCARDITIS. TREATMENT INCLUDED MEDICATION, BALLOON INTERVENTION OR EXPLANT. BASED ON THE AVAILABLE INFORMATION A 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
    1526814 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention