BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 3870049 · Received June 12, 2014

    Report

    Report Number
    2025587-2014-00375
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED/WAS NOT RETURNED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    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 AN ABSTRACT OF THE JOURNAL OF (B)(6) MEDICAL ASSOCIATION ON A RETROSPECTIVE STUDY (MAY 2007- JULY 2011) TO EVALUATE THE OUTCOMES OF IMPLANTATION OF THE CONTEGRA VALVED CONDUIT IN 16 PEDIATRIC AND ADULT PATIENTS IN (B)(6). THREE OF THE 16 PATIENTS WERE IN-HOSPITAL DEATHS WHICH WERE REPORTED TO NOT BE RELATED TO THE CONDUIT. ONE PATIENT WAS LOST TO FOLLOW UP. ONE OF THE REMAINING 12 PATIENTS HAD SEVERE VALVULAR REGURGITATION WITH IN INTERVENTION AND ANOTHER PATIENT NEEDED DISTAL PULMONARY ARTERY DILATATION DUE TO STENOSIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348571 CONTEGRA PULMONARY VALVED CONDUIT CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention