BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 7848026 · Received September 5, 2018

    Report

    Report Number
    2025587-2018-02344
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    October 16, 2017
    Report Date
    September 5, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SOLANA-GRACIA R PEDIATRICS SPANISH REGISTRY OF PERCUTANEOUS MELODY PULMONARY VALVE IMPLANTATION IN PATIENTS YOUNGER THAN 18 YEARS. REV ESP CARDIOL (ENGL ED). 2018 APR;71(4):283-290. DOI: 10.1016/J.REC.2017.07.013. EPUB 2017 OCT 16. 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. WITHOUT THE 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 FROM PEDIATRICS SPANISH REGISTRY ON PERCUTANEOUS MELODY PULMONARY VALVE IMPLANTATION IN PATIENTS YOUNGER THAN 18 YEARS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN MARCH 2007 AND JANUARY 2017. 81 MEDTRONIC MELODY VALVES WERE IMPLANTED IN 77 PATIENTS (PREDOMINANTLY MALE, MEDIAN AGE 13 YEARS). ONE PATIENT UNDERWENT A DOUBLE IMPLANTATION BECAUSE HE HAD A DOUBLE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) (CONDUIT + NATIVE RVOT) AND 3 PATIENTS REQUIRED A SECOND MELODY VALVE (2 VIA THE VALVE-IN-VALVE TECHNIQUE AND THE OTHER AFTER EXPLANTATION OF THE INITIAL VALVE AND SURGICAL RECONSTRUCTION OF THE RVOT).ONE PATIENT HAD A PREVIOUSLY IMPLANTED CONTEGRA VALVED CONDUIT. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 1 DEATH OCCURRED DUE TO INFECTIVE ENDOCARDITIS. THE TIME FROM IMPLANT TO INFECTION WAS NOT CLEARLY STATED FOR THIS PATIENT; HOWEVER, PER TABLE 4 THE SHORTEST TIME FRAME COULD HAVE BEEN 100 DAYS POST-IMPLANT. INSUFFICIENT INFORMATION RECEIVED TO REASONABLY SUGGEST THAT THE DEVICE CAUSED/CONTRIBUTED TO A REPORTABLE EVENT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: IATROGENIC AORTOPULMONARY WINDOW AND TRICUSPID VALVE INJURY REQUIRING INTERVENTION, MODERATE TRICUSPID REGURGITATION, VENTRICULAR TACHYCARDIA, MILD PARAVALVULAR LEAK (PVL), PULMONARY EDEMA, SEVERE PULMONARY REGURGITATION REQUIRING REINTERVENTION WITH BALLOON DILATION, OR VALVE-IN-VALVE, ENDOCARDITIS REQUIRING SURGICAL EXTRACTION OF THE VALVE. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. AMONG ALL PATIENTS, ADVERSE EVENTS RELATED TO ENSEMBLE DELIVERY SYSTEM INCLUDED: FEMORAL THROMBOSIS. AMONG ALL PATIENTS, ADVERSE EVENTS RELATED TO CONTEGRA INCLUDED: ENDOCARDITIS. AMONG ALL PATIENTS, DEVICE MALFUNCTIONS RELATED TO MELODY INCLUDED: STENT FRACTURE. BASED ON THE AVAILABLE INFORMATION, THIS MALFUNCTION 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
    687330 VALVE CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention