BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC ULTRA PORCINE HEART VALVE

    MDR report key: 3970788 · Received July 31, 2014

    Report

    Report Number
    2025587-2014-00538
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 27, 2014
    Report Date
    August 15, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THAT THERE WERE NO ALLEGATIONS AGAINST THE DEVICE, AND THAT THE PARAVALVULAR LEAK WAS ASSOCIATED WITH THE INITIAL PHYSICIAN'S IMPLANT TECHNIQUE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT BE RETURNED FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (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 THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, A PARAVALVULAR LEAK (PVL) WAS NOTED. THE VALVE WAS REMOVED BY A SECOND PHYSICIAN, WHO IMPLANTED A SECOND VALVE WITH NO ADVERSE PATIENT EFFECTS. THE SECOND PHYSICIAN INDICATED THAT THE PVL WAS DUE TO THE IMPLANT TECHNIQUE OF THE FIRST PHYSICIAN, AND THAT THERE WERE NO DEVICE-RELATED ISSUES ASSOCIATED WITH THE FIRST VALVE¿S PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447207 MOSAIC ULTRA PORCINE HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305U2J19

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention