BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 15061442 · Received July 19, 2022

    Report

    Report Number
    2025587-2022-01967
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    August 26, 2021
    Report Date
    July 19, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SIVAPRAKASAM M.; ET AL. EARLY MULTICENTER EXPERIENCE OF A NEW BALLOON EXPANDABLE MYVAL TRANSCATHETER HEART VALVE IN DYSFUNCTIONAL STENOSED RIGHT VENTRICULAR OUTFLOW TRACT CONDUITS. ANN PEDIATR CARDIOL. 2021 JUL-SEP;14(3):293-301. DOI: 10.4103/APC.APC_242_20. PMID: 34667399. EPUB 2021 AUG 26. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING CLINICAL TRIALS OF A NEW BALLOON-EXPANDABLE TRANSCATHETER IMPLANTABLE VALVE FOR USE IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM CASE RECORDS FROM MULTIPLE INDIAN MEDICAL CENTERS. THE STUDY POPULATION INCLUDED SEVEN PATIENTS, INVOLVING A MIXTURE OF TEENAGE AND ADULT PATIENTS WHO HAD ALL UNDERGONE PRIOR SURGICAL REPAIRS OF CONGENITAL HEART DISEASE AND LATER DEVELOPED RVOT STENOSIS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THREE PATIENTS (TWO FEMALE: 1 MALE, MEAN AGE 21 YEARS, MEAN WEIGHT 46.3 KG) HAD PREVIOUSLY UNDERGONE SURGICAL IMPLANTATION IN THE RVOT WITH MEDTRONIC CONTEGRA BIOPROSTHETIC VALVED CONDUITS BETWEEN 2009-2012 (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). ALL PATIENTS UNDERWENT RVOT STENTING AND THEN TRANSCATHETER PULMONARY VALVE IMPLANTATION (TPVI) WITH 23-MM NON-MEDTRONIC VALVES. AMONG THE THREE MEDTRONIC CONTEGRA PATIENTS, ADVERSE EVENTS INCLUDED: RVOT/PULMONIC CONDUIT STENOSIS WITH ELEVATED TRANS-CONDUIT GRADIENTS REQUIRING TPVI AND STENTING TO RESOLVE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    401283 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention