BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALL EASY FIT

    MDR report key: 6668744 · Received June 26, 2017

    Report

    Report Number
    3008592544-2017-00037
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 2, 2017
    Report Date
    July 17, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS DEVICE WAS REPLACED DUE TO ENDOCARDITIS. ALONG WITH THE ENDOCARDITIS, THE PATIENT WAS EXTREMELY SICK, INCLUDING SEPTIC SHOCK, AND A POSSIBLE AORTIC ABSCESS. THE PATIENT INITIALLY DID WELL POST-OPERATIVELY. HOWEVER, THE PATIENT HAS SUBSEQUENTLY BEEN READMITTED FOR AN AORTIC VALVE REPLACEMENT PROCEDURE. PATIENT WEIGHT ADDED. PATIENT'S RELEVANT MEDICAL HISTORY ADDED. PATIENT CODES UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE OCCURRENCE OF ENDOCARDITIS WAS GREATER THAN 12 MONTHS POST IMPLANT (OVER 27 YEARS). 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. ALSO, A DHR REVIEW IS NOT REQUIRED AS THE VALVE HAS BEEN IMPLANTED FOR OVER 27 YEARS, IT¿S VERY UNLIKELY THAT THE ENDOCARDITIS IS DUE TO ANY POTENTIAL MANUFACTURING ISSUE. NO FORMAL INVESTIGATION IS RECOMMENDED. WITHOUT THE RETURN OF THE VALVE, A CONCLUSIVE CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. ENDOCARDITIS RELATED RISKS ARE ADDRESSED IN THE CURRENT RISK MANAGEMENT FILE. MEDTRONIC WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR SIMILAR EVENTS SHOULD THEY OCCUR. NOTE 1 - MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV.1, 2001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT TWENTY SEVEN YEARS, TWO MONTHS POST IMPLANT OF THIS MECHANICAL VALVE, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448781 HALL EASY FIT HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. M7700-33

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention