BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    MDR report key: 6153131 · Received December 7, 2016

    Report

    Report Number
    2025587-2016-01954
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 15, 2016
    Report Date
    January 9, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K072655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE WAS MANUFACTURED AT (B)(4) (ORIGINAL MANUFACTURER). 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. CASES THAT OCCUR WITHIN TWO MONTHS AFTER THE PROCEDURE ARE CALLED EARLY PROSTHETIC-VALVE ENDOCARDITIS, AND ARE USUALLY ACQUIRED WHILE THE PATIENT IS IN THE HOSPITAL (NOSOCOMIAL INFECTION). THESE CASES MAY ALSO BE DUE TO INTRODUCTION OF THE MICROORGANISM DURING THE IMPLANT PROCEDURE. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE TRUE CAUSE OF INFECTION. IT COULD NOT BE DETERMINED IF THE ENDOCARDITIS WAS RELATED TO THE DEVICE AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV.1, 2001. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 12 DAYS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH LOW BLOOD PRESSURE. THE PATIENT WAS SEPTIC WITH INFECTION OF THE PATIENT'S DEVICE AND NATIVE MITRAL VALVE. BLOOD CULTURES INDICATED THAT THE ORGANISM WAS STAPH AUREUS. IT COULD NOT BE DETERMINED IF THE ENDOCARDITIS WAS RELATED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804157 SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 800SR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention