BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 9980009 · Received April 20, 2020

    Report

    Report Number
    2024168-2020-03776
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    January 27, 2020
    Report Date
    April 20, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF HEMATOMA, HYPERSENSITIVITY, WEAKNESS, RENAL FAILURE AND TEST RESULT AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE HEMATOMA, RENAL FAILURE AND HYPERSENSITIVITY. THE REPORTED WEAKNESS AND TEST RESULTS APPEAR TO BE CASCADING EFFECTS OF THE RENAL FAILURE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE ALLERGIC REACTION. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2019 TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 3-4. ONE CLIP WAS IMPLANTED, REDUCING MR TO 1. ON (B)(6) 2020, THE PATIENT ACQUIRED VON WILLEBRAND SYNDROME, MANIFESTED AS GENERALIZED PURPURA AND EPISTAXIS LASTING > 1 DAY. STEROIDS WERE PROVIDED FOR TREATMENT. ON (B)(6) 2020, THE PATIENT PRESENTED WITH UNEXPLAINED MUSCLE WEAKNESS AND RENAL IMPAIRMENT AND WAS READMITTED TO THE HOSPITAL FROM THE REHABILITATION HOSPITAL. TEST RESULTS SHOWED HYPOALBUMINEMIA, POSITIVE DIRECT COOMBS, INCREASED EOSINOPHILS, AND INCREASED IMMUNOGLOBULIN E (IGE). PER THE PHYSICIAN THE POSSIBILITY OF ALLERGY CAUSED BY THE MITRACLIP DEVICE CANNOT BE RULED OUT AS A CAUSE OF EOSINOPHILIA OR IGE ELEVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440464 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT VALVE REPAIR NKM ABBOTT VASCULAR 90629U183

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization