BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 10005467 · Received April 28, 2020

    Report

    Report Number
    2024168-2020-03947
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    February 16, 2020
    Report Date
    July 27, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.

    Additional Manufacturer Narrative · 0

    B3, D6: DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE ENDOCARDITIS. THE REPORTED PATIENT EFFECT OF ENDOCARDITIS IS LISTED IN THE MITRACLIP NTR/XTR INSTRUCTION FOR USE AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    EVENT DATES ESTIMATED. LITERATURE ATTACHMENT: MITRACLIP-ASSOCIATED ENDOCARDITIS: EMERGENCY DEPARTMENT DIAGNOSIS WITH POINT OF CARE ULTRASOUND.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT POST PROCEDURE, ENDOCARDITIS OCCURRED. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP DEVICE WHICH MAY BE RELATED TO INFECTIVE ENDOCARDITIS (IE), RE-HOSPITALIZATION, MEDICAL INTERVENTION AND SURGERY. SPECIFIC INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, MITRACLIP-ASSOCIATED ENDOCARDITIS: EMERGENCY DEPARTMENT DIAGNOSIS WITH POINT OF CARE ULTRASOUND. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468353 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R