BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONDUIT CONTEGRA

    MDR report key: 3899594 · Received June 27, 2014

    Report

    Report Number
    2025587-2014-00424
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    January 10, 2013
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. THE ARTICLE CONCLUDED THAT ALTHOUGH THIS PATIENT EXPERIENCED MULTIFOCAL THROMBOSIS THAT NECESSITATED STENTING OF THIS DOWNSIZED GRAFT, USE OF THE MODIFIED DEVICE ENABLED CLEARANCE OF PURULENT MEDIASTINITIS. IN THE SETTING OF MULTIFOCAL THROMBOSIS, IT WAS UNCLEAR WHETHER THE LEAFLETS WITHIN THE CONDUIT CONTRIBUTED TO THROMBOTIC OBSTRUCTION OF THE GRAFT. ANN THORAC SURG 2013:96:1077-8 DOI: 10.1016/J.ATHORACSUR.2013.01.039 HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2013.01.039 (B)(4).

    Additional Manufacturer Narrative · 1

    ALTHOUGH THESE BOVINE JUGULAR VEIN GRAFTS ARE COMMONLY USED FOR RIGHT VENTRICLE¿TO¿PULMONARY ARTERY RECONSTRUCTION, THEY ARE NOT AVAILABLE IN SIZES SUITABLE FOR NEONATAL VENTRICULOPULMONARY CONDUITS. THE PRODUCT REMAINS IMPLANTED, AND THE SERIAL NUMBER WAS NOT PROVIDED, THEREFORE NO ANALYSIS COULD BE CONDUCTED AND A DEVICE HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED. REDUCED PERFORMANCE OF THE DEVICE IS ATTRIBUTED TO THROMBUS, WHICH IS GENERALLY CONSIDERED A PATIENT-RELATED CONDITION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A MEDICAL JOURNAL ARTICLE THAT THIS TRANSCATHETER PULMONARY VALVED CONDUIT WAS MODIFIED FOR IMPLANT INTO AN INFECTED, DEHISCED RIGHT VENTRICLE-TO-PULMONARY ARTERY CONDUIT IN A NEONATE WITH LIFE-THREATENING PURULENT MEDIASTINITIS. THE DIAMETER OF THE CONDUIT WAS REDUCED BY MAKING PARALLEL LONGITUDINAL INCISIONS ALONG THE LENGTH OF THE GRAFT, EXCISING A STRIP OF THE CONDUIT THAT INCLUDED ONE LEAFLET. THE GRAFT WAS THEN RECONSTRUCTED OVER ANOTHER MANUFACTURER¿S 6 MILLIMETER DILATOR WITH RUNNING POLYPROPYLENE SUTURE. THE DOWNSIZED GRAFT WAS THEN USED AS THE RIGHT VENTRICLE¿TO¿PULMONARY ARTERY CONDUIT. TRANSTHORACIC ECHOCARDIOGRAPHY PERFORMED ON THE SIXTH POSTOPERATIVE DAY REVEALED A PROXIMAL GRADIENT OF 0.9 M/S AND A DISTAL GRADIENT OF 3.2 M/S WITHIN THIS DEVICE. THIRTEEN DAYS POST-IMPLANT, THE PATIENT DEVELOPED ACUTE HYPOXIA AND WAS ADMINISTERED VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) USING A DUAL-LUMEN CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN. CARDIAC CATHETERIZATION ON ECMO REVEALED THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA, LEFT INNOMINATE VEIN, AND THE RIGHT VENTRICLE¿TO¿PULMONARY ARTERY SHUNT. PATENCY OF THE SHUNT WAS ATTAINED BY PERCUTANEOUS STENT PLACEMENT. THE PATIENT THEN COMPLETED A SIX-WEEK COURSE OF ANTIBIOTIC THERAPY, AND NO ADVERSE PATIENT EFFECTS SUBSEQUENTLY WERE NOTED AT THE PATIENT'S ONE-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377876 VALVE CONDUIT CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION PVC212

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 DA Required Intervention