BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC 25MM

    MDR report key: 5958243 · Received September 16, 2016

    Report

    Report Number
    2025587-2016-01485
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    November 18, 2015
    Report Date
    September 7, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EFFECT OF VALVULAR SURGERY IN CARCINOID HEART DISEASE: AN OBSERVATIONAL COHORT STUDY CITATION: THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM (2016) 101(1):183¿190 DOI 10.1210/JC.2015-3295. AUTHORS: N. C. EDWARDS, M. YUAN, O. NOLAN, T. A. PAWADE, T. OELOFSE, H. SINGH, H. MEHRZAD, Z. ZIA, J. I. GEH, D. H. PALMER, C. J. H. MAY, J. AYUK, T. SHAH, S. J. ROONEY, AND R. P. STEEDS. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    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 VIA LITERATURE REVIEW REGARDING VALVULAR SURGERY IN PATIENTS WITH CARCINOID HEART DISEASE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2005 AND 2015. THE STUDY POPULATION INCLUDED 47 PATIENTS, 32 OF WHICH WERE TREATED WITH A SURGICAL INTERVENTION. OF THE SURGICAL GROUP (16 MALE AND 16 FEMALE; MEAN AGE 68 YEARS), 10 WERE IMPLANTED WITH MEDTRONIC HANCOCK BIOPROSTHETIC SURGICAL VALVE IMPLANTED IN THE TRICUSPID POSITION (SERIAL NUMBERS NOT PROVIDED). AMONG ALL SURGICAL PATIENTS ADVERSE EVENTS INCLUDED: 13 INCIDENTS OF HEART BLOCK THAT REQUIRED TREATMENT WITH A PERMANENT PACEMAKER. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608502 HANCOCK II AORTIC 25MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505-25H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention