BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 5756587 · Received June 28, 2016

    Report

    Report Number
    2025587-2016-00949
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    May 13, 2016
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED DUE TO ENDOCARDITIS. THERE WAS NO INDICATION OF A POSITIVE BLOOD CULTURE AND NO ORGANISM WAS IDENTIFIED. THE PATIENT HAS A HISTORY OF INTRAVENOUS (IV) DRUG ABUSE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. 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

    CONCLUSION: 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 PRODUCT SPECIMEN FOR DEVICE ANALYSIS, A DEFINITIVE ROOT CAUSE TO THE REPORTED EVENT COULD NOT BE DETERMINED. BASED ON THE RECEIVED INFORMATION, THE ENDOCARDITIS MAY POSSIBLY BE DUE TO PATIENT CONDITION / RELEVANT MEDICAL HISTORY. IN ADDITION, THIS EVENT THE OCCURRENCE OF ENDOCARDITIS WAS GREATER THAN 12 MONTHS POST IMPLANT. BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM THE JOURNAL LITERATURE, COMPLAINTS WHICH OCCURRED GREATER THAN 12 MONTHS POST IMPLANT WERE LARGELY CONSIDERED TO BE COMMUNITY ACQUIRED (REFER TO NOTE 1). THEREFORE, IT WAS UNLIKELY THAT THE ENDOCARDITIS ORIGINALLY CAME FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. NOTE 1 - MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV.1, 2001.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT SPECIMEN HAS NOT BEEN RETURNED FOR DEVICE EVALUATION. CONCLUSION: MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST PRODUCT RETURN AND ADDITIONAL INFORMATION; HOWEVER, THESE ATTEMPTS HAVE BEEN WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 1 YEARS AND 9 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED FOR REASONS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408813 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310C

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention