BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 9437067 · Received December 9, 2019

    Report

    Report Number
    2024168-2019-14275
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 7, 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 · 0

    EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. 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. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). THE INVESTIGATION DETERMINED THE REPORTED PATIENT EFFECTS WERE NOT RELATED TO THE DEVICE AS IT WAS REPORTED THAT THE PHYSICIAN STATED THAT THE CLIPS DID NOT CAUSE OR CONTRIBUTE TO THE LIVER DYSFUNCTION OR SHOCK. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CORRECTION: DEVICE CODE 2993 REMOVED; PATIENT CODE 2072 REMOVED.

    Additional Manufacturer Narrative · 0

    G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. THE CLIP REMAINS IN PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE CLIPS REMAIN STABLE ON THE LEAFLETS. THE PHYSICIAN STATED THAT THE CLIPS DID NOT CAUSE OR CONTRIBUTE TO THE LIVER DYSFUNCTION OR SHOCK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THIS IS BEING FILED TO REPORT SHOCK. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO FUNCTIONAL TREAT MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ON (B)(6) 2019, TWO CLIPS (90629U196, 90629U193) WERE IMPLANTED, REDUCING MR TO 1-2. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ON (B)(6) 2019, THE TEST RESULTS SHOWED HYPOGLYCEMIAS AND LIVER DYSFUNCTION. HEMOLYSIS WAS NOT IN THE URINE AND HEPATOMEGALY INCREASED. THIS IS POSSIBLY AN INDICATION OF A LIVER DISORDER. FASTING AND FLUID MANAGEMENT WERE OBSERVED FOR PROGRESS. LOW REFLUX DURING ANESTHESIA MANAGEMENT SUCH AS SHOCK LIVER IS SUSPECTED. IT IS UNKNOWN AT THIS TIME IF THE CLIPS CAUSED OR CONTRIBUTED TO THE SHOCK. THE SHOCK HAS NOT BEEN TREATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230734 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR 90629U196

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 1 IMPLANTED MITRACLIP