BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6114307 · Received November 18, 2016

    Report

    Report Number
    2025587-2016-01815
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    March 8, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MEHMET SALIH BILAL, MD; DOUBLE SWITCH PROCEDURE AND SURGICAL ALTERNATIVES FOR THE TREATMENT OF CONGENITALLY CORRECTED TRANSPOSITION OF THE GREAT ARTERIES JOURNAL OF CARDIAC SURGERY 2016: 31(4):231-6: 10.1111/JOCS.12728. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION ,IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE DOUBLE SWITCH OPERATION IN PATIENTS WITH CONGENITALLY CORRECTED TRANSPOSITION OF THE GREAT ARTERIES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1995 AND 2015. THE STUDY POPULATION INCLUDED 16 PATIENTS, PREDOMINANTLY MALE; BETWEEN 4 MONTHS AND 72 MONTHS OF AGE, OF WHICH 3 WERE IMPLANTED WITH MEDTRONIC FREESTYLE BIOPROSTHESIS AND CONTEGRA PULMONARY VALVED CONDUIT (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, LONG TERM OUTCOMES INCLUDED: REOPERATION FOR CONDUIT THROMBOSIS AND CONDUIT REPLACEMENT (CONTEGRA), AND PERMANENT PACEMAKER DUE TO AV BLOCK. BASED ON THE AVAILABLE INFORMATION, THESE WERE THE ONLY ADVERSE EVENTS ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765192 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 50 MO Required Intervention