BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC AP

    MDR report key: 5457349 · Received February 24, 2016

    Report

    Report Number
    3008592544-2016-00010
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    January 17, 2016
    Report Date
    March 21, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ENDOCARDITIS WAS DEEMED THE MAIN REASON FOR REPLACEMENT AND WAS THE CAUSE OF SECONDARY SYMPTOMS. BLOOD CULTURES WERE POSITIVE AND ENTEROCOCCI WERE IDENTIFIED. PRODUCT ANALYSIS: THE PRODUCT SPECIMEN HAS BEEN DISCARDED BY THE MEDICAL INSTITUTION. 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. IN THIS EVENT, THE OCCURRENCE OF THE REPORTED ENDOCARDITIS WAS GREATER THAN 12 MONTHS POST IMPLANT. BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM JOURNAL LITERATURE, COMPLAINTS WHICH OCCURRED GREATER THAN 12 MONTHS POST IMPLANT WERE LARGELY CONSIDERED TO BE COMMUNITY ACQUIRED (REFER TO NOTE 1 BELOW). THEREFORE, IT WAS UNLIKELY THAT THE ENDOCARDITIS ORIGINALLY CAME FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. CONSIDERING THE INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED HEART FAILURE AND CORONARY ARTERY DISEASE COULD NOT BE ESTABLISHED. WITHOUT THE RETURN OF THE VALVE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. 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

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (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 7 YEARS AND 9 MONTHS POST IMPLANT OF THIS MECHANICAL VALVE, IT WAS REPLACED WITH A LARGER MECHANICAL VALVE DUE TO SEVERE AORTIC INSUFFICIENCY, ENDOCARDITIS, DEHISCENCE, AND STENOSIS. THE PATIENT WAS HOSPITALIZED FOR EIGHT WEEKS PRIOR TO THE PROCEDURE DUE TO ENDOCARDITIS AND TREATED WITH ANTIBIOTICS. THE PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS; HOWEVER, EACH OF THE ABOVE MENTIONED ADVERSE PATIENT EFFECTS REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114958 AORTIC AP HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 501DA

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R