BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE BAND

    MDR report key: 8712445 · Received June 19, 2019

    Report

    Report Number
    2025587-2019-01977
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    December 12, 2018
    Report Date
    June 19, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ARNAZ A. PULMONARY VALVE REPLACEMENT IN PATIENTS WITH REPAIRED TETRALOGY OF FALLOT: EARLY RESULTS FOR RECOVERY OF RIGHT VENTRICULAR DILATATION AND QRS DURATION. TURK J MED SCI, 2018; 48: 1121-1128. DOI: 10.3906/SAG-1805-66. 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. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 EARLY OUTCOMES OF PULMONARY VALVE REPLACEMENT IN PATIENTS WITH REPAIRED TETRALOGY OF FALLOT (TOF) CONGENITAL HEART DISEASE AND SEVERE PULMONARY REGURGITATION. ALL DATA WERE COLLECTED IN A RETROSPECTIVE ANALYSIS FROM A SINGLE CENTER BETWEEN MARCH 2005 AND OCTOBER 2017. THE STUDY POPULATION INCLUDED 32 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 16.57 YEARS), 1 OF WHICH WAS IMPLANTED WITH A MEDTRONIC DURAN ANCORE BIOPROSTHESIS (NO SERIAL NUMBER PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: 2 PATIENTS UNDERWENT PULMONARY VALVE REPLACEMENT DUE TO ENDOCARDITIS AND VALVE DEGENERATION AT 4 AND 10 YEARS POST-IMPLANT, AND 1 PATIENT UNDERWENT BALLOON VALVULOPLASTY 6 YEARS POST-IMPLANT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504436 DURAN ANCORE BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620B

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R