BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 4786421 · Received May 20, 2015

    Report

    Report Number
    2025587-2015-00578
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 27, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: CARDIAC DYSRHYTHMIAS (I.E. ELECTROCARDIOGRAPHIC CHANGES) ARE KNOWN POTENTIAL ADVERSE EVENTS PER MOSAIC INSTRUCTIONS FOR USE (IFU). THESE ISSUES CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER. BASED ON THE RECEIVED INFORMATION, IT WAS UNCLEAR WHETHER THE PACEMAKER IMPLANT WAS RELATED TO ANY VALVE ISSUES. WITH THE LIMITED INFORMATION RECEIVED, A ROOT CAUSE OF THE HIGH GRADIENT CANNOT BE DETERMINED. PANNUS FORMATION HAS BEEN AN INHERENT RISK OF SURGICAL VALVE REPLACEMENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN DETAILS REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL. THE DATE OF EVENT AND IMPLANT DATE ARE APPROXIMATIONS. THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND SYNCOPE, NECESSITATING A PERMANENT PACEMAKER BE IMPLANTED. AN ECHOCARDIOGRAM MEASURED GRADIENT LEVELS OF 80 MMHG AND INDICATIONS OF PANNUS FORMATION ON THE VALVE. MODERATE MITRAL REGURGITATION WAS ALSO NOTED. NO FURTHER INTERVENTION WAS PRESCRIBED AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328453 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention