BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-23 3F AORTIC BIO 23MM

    MDR report key: 2568170 · Received May 10, 2012

    Report

    Report Number
    2031780-2012-00003
    Event Type
    Injury
    Date Received
    May 10, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(6).

    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 APPROXIMATELY THREE YEARS FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED CENTRAL AND PARAVALVULAR REGURGITATION. IT WAS REPORTED THAT TWO COMMISSURE TABS WERE LOOSE (LEFT-RIGHT CORONARY AND LEFT-NONCORONARY COMMISSURES), AND APPEARED TO BE SEWN WITH A SINGLE PROLENE WITH NO PLEDGET ON THE OUTSIDE OF THE AORTA. THE LEFT-NONCORONARY COMMISSURE TAB WAS SEPARATED FROM THE SINOTUBULAR JUNCTION ABOUT 4MM. THE VALVE WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS. THE VALVE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THV 1000-23 3F AORTIC BIO 23MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC ATS 3F THERAPEUTICS 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention