BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 6031373 · Received October 14, 2016

    Report

    Report Number
    2025587-2016-01626
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    October 25, 2012
    Report Date
    September 17, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCLUDING PMA / 510(K) #: P990064.

    Additional Manufacturer Narrative · 1

    CITATION: JEGANATHAN R ET AL. THE RISK AND OUTCOMES OF REOPERATIVE TRICUSPID VALVE SURGERY. ANN THORAC SURG 2013;95:119 ¿25. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. (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 VIA LITERATURE REGARDING AN EVALUATION OF REOPERATIVE TRICUSPID VALVE SURGERY. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MAY 1979 AND JANUARY 2011. THE STUDY POPULATION CONSISTED OF 68 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE OF 60 YEARS), 35 OF WHICH WERE IMPLANTED WITH MEDTRONIC PRODUCTS INCLUDING 25 HANCOCK II, 3 MOSAIC, 3 DURAN RING, AND 4 WITH A SIMPLICI-T BAND (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 34 DEATHS (9 EARLY AND 25 LATE) OCCURRED; NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS NON-DEATH ADVERSE EVENTS INCLUDED: RE-OPERATION FOR BLEEDING, LOW CARDIAC OUTPUT SYNDROME, RENAL FAILURE, CONDUCTION DISTURBANCES WITH PERMANENT PACEMAKER IMPLANT, STROKE, PULMONARY COMPLICATIONS, LATE COMPLICATION OF ENDOCARDITIS, AND TRICUSPID REGURGITATION SPECIFIC TO PATIENTS IMPLANTED WITH AN ANNULOPLASTY RING OR BAND. 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
    681533 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention