BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 6527873 · Received April 27, 2017

    Report

    Report Number
    2025587-2017-00707
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    September 28, 2014
    Report Date
    May 8, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BRIZARD C ET AL. INTRA-ANNULAR MITRAL VALVE REPLACEMENT IN NEONATES AND INFANTS. 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    REVIEW OF MEDTRONIC'S GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED SERIAL NUMBER REVEALED NO PRIOR RECORDS OR SUBMITTED REGULATORY REPORTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A NEONATE ((B)(6)) WITH HYPOPLASTIC AORTIC ARCH, MILD MITRAL STENOSIS AND PATENT DUCTUS ARTERIOSUS WHO UNDERWENT IMPLANT OF A MEDTRONIC CONTEGRA CONDUIT (SERIAL NUMBER NOT INCLUDED). FOLLOWING A SUCCESSFUL IMPLANT PROCEDURE, THE PATIENT RECOVERED WELL AND WAS DISCHARGED HOME THREE WEEKS POSTOPERATIVE. AT 12-MONTH FOLLOW UP GRADIENTS HAD PROGRESSIVELY INCREASED TO 18 MMHG WITH PRESERVED VENTRICULAR FUNCTION AND NO MITRAL REGURGITATION (MR). AT 14 MONTHS POSTOPERATIVE, A BALLOON VALVULOPLASTY WAS PERFORMED. TWO MONTHS LATER, THE GRADIENTS HAD IMPROVED TO 8 MMHG WITH MILD MR. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR PROVIDED THE CONDUIT SERIAL NUMBER ((B)(4)), THE PATIENT¿S GENDER (FEMALE), AND STATED THAT THE PATIENT EXPERIENCED AN OUTSTANDING OUTCOME WITH THE CONDUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308265 VALVE CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION PVC212

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention