BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 4211478 · Received October 29, 2014

    Report

    Report Number
    2025587-2014-00814
    Event Type
    Death
    Date Received
    October 29, 2014
    Date of Event
    July 1, 2013
    Report Date
    November 11, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH NO DEVICE- OR PATIENT-IDENTIFYING INFORMATION, MEDTRONIC¿S COMPLAINT DATABASE COULD NOT BE SEARCHED TO IDENTIFY ANY PREVIOUSLY REPORTED COMPLAINTS THAT MAY HAVE BEEN INCLUDED IN THIS ARTICLE. THE REPORTED DATE OF DEATH IS AN ARBITRARY VALUE ENTERED TO FACILITATE ELECTRONIC SUBMISSION OF THIS REPORT. (B)(4). NEW TECHNOLOGIES FOR SURGERY OF THE CONGENITAL CARDIAC DEFECT AUTHORS: DAVID KALFA, M.D., PH.D. AND EMILE BACHA, M.D. RAMBAM MAIMONIDES MEDICAL JOURNAL JULY 2013 - VOLUME 4 - ISSUE 3 - E0019 DOI:10.5041/RMMJ.10119.

    Additional Manufacturer Narrative · 1

    DEATH, STENOSIS, REGURGITATION, AND PSEUDOANEURYSMS ARE KNOWN POTENTIAL ADVERSE EVENTS FOR THIS DEVICE. AS THE DEVICES EITHER WERE NOT RETURNED FOR EVALUATION OR IDENTIFIED TO DETERMINE IF A DEVICE HAD PREVIOUSLY BEEN RETURNED FOR ANALYSIS, A FAILURE MECHANISM WAS NOT ABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA A LITERATURE REVIEW ARTICLE REGARDING THE USE OF NEW DEVICES IN CONGENITAL HEART DEFECT REPAIR SURGERY THAT REOPERATION ASSOCIATED WITH FAILED VALVED CONDUITS WAS ASSOCIATED WITH A MORTALITY RATE OF 1%-3% AT THE TIME OF THE REVIEW. THE MORTALITY RATE WAS REPORTED FOR ALL SIMILAR PRODUCTS EXAMINED IN THE LITERATURE, WHICH INCLUDED MODELS FROM THIS FAMILY OF PULMONARY VALVED CONDUITS. THE ARTICLE WAS BASED ON A REVIEW OF PUBLISHED LITERATURE AND DID NOT INCLUDE DETAILS REGARDING THE NUMBER OR DATES OF DEVICE IMPLANTS OR DEATHS, OR PATIENT DEMOGRAPHICS, AND DID NOT SPECIFICALLY ASSOCIATE THE DEATHS WITH DEVICE LIMITATIONS. REPORTED DEVICE LIMITATIONS INCLUDED IMMUNOGENICITY AND INFLAMMATORY RESPONSE, STENOSIS OF THE DISTAL ANASTOMOSIS, PSEUDOANEURYSM OF THE PROXIMAL ANASTOMOSIS, AND SEVERE CONDUIT REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694074 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R