BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3951079 · Received July 22, 2014

    Report

    Report Number
    2025587-2014-00504
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 4, 2012
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EXPLANT, THE TPV WAS FORWARDED TO ANOTHER FACILITY FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED OR IF THE DEVICE IS RETURNED TO MEDTRONIC FOR ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    HAEMOPHILUS PARAINFLUENZAE IS PART OF THE NORMAL HUMAN OROPHARYNX FLORA AND IS A MEMBER OF THE HACEK GROUP OF RARE BACTERIA THAT IS RESPONSIBLE FOR ABOUT 3% OF ENDOCARDITIS CASES. 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. A REVIEW OF THE STERILITY LOT RECORD CONFIRMED THAT THE BIOLOGICAL INDICATORS (BI) TESTED NEGATIVE FOR BOTH TISSUE AND SOLUTION. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS, OR COMPLAINTS FOR INFECTION AGAINST ANY OF THE DEVICES MANUFACTURED UNDER THIS STERILITY LOT. THE STERILIZATION PROCESS USED BY MEDTRONIC HAS AN ANTI-MICROBIAL KILL ON THE MICROORGANISMS SUCH AS STAPHYLOCOCCUS AND STREPTOCOCCUS SPECIES. THE INFORMATION RECEIVED INDICATES THAT THE ENDOCARDITIS OCCURRED 2 YEARS POST IMPLANT. ENDOCARDITIS THAT OCCURS MORE THAN 12 MONTH AFTER THE PROCEDURE ARE CALLED LATE PROSTHETIC-VALVE ENDOCARDITIS AND ARE LARGELY COMMUNITY-ACQUIRED VERSUS A RESULT OF THE MANUFACTURING PROCESS OF THE VALVE. BASED ON THE ABOVE INVESTIGATION, THE ENDOCARDITIS IS UNLIKELY TO BE ATTRIBUTED TO THE MELODY TPV DEVICE AND/OR MANUFACTURING PROCESS. A ROOT CAUSE OF THE REPORTED CLINICAL OBSERVATIONS COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION THAT THE REPORTED ENDOCARDITIS WAS RELATED TO THE MANUFACTURE OF THE DEVICE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS/INVESTIGATION WILL BE UPDATED AND A SUPPLEMENTAL REPORT SUBMITTED IF THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED INTO A STENOTIC CONDUIT AFTER THE CONDUIT WAS PRE-STENTED. TWO YEARS POST-IMPLANT, THE PATIENT WAS ADMITTED TO A HOSPITAL WITH A FEVER. AN ECHOCARDIOGRAM SHOWED NO VEGETATION AND BLOOD CULTURES WERE STERILE. ANTIBIOTICS WERE PRESCRIBED WITH NO IMPROVEMENT. THE PATIENT WAS TRANSFERRED TO THE DEVICE IMPLANT CENTER, WHERE AN ECHOCARDIOGRAM SHOWED THE TPV WAS STENOTIC, AND HEMOPHILUS PARAINFLUENZA WAS IDENTIFIED IN BLOOD CULTURES. AFTER SUCCESSFUL TREATMENT WITH ANTIBIOTICS, THE TPV WAS EXPLANTED AND A NON-MEDTRONIC AORTIC HOMOGRAFT WAS IMPLANTED INSIDE THE CONDUIT. AT EXPLANT, THE TPV REVEALED PARTIALLY-DESTRUCTED THICKENED LEAFLETS WITH A YELLOW SMEAR. CULTURES OF THE SMEAR REMAINED STERILE. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427933 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention