BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 18283212 · Received December 7, 2023

    Report

    Report Number
    2135147-2023-05360
    Event Type
    Death
    Date Received
    December 7, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A2, A4: PATIENT DEMOGRAPHICS OBTAINED FROM BASELINE DATA ON 15-NOV-2021 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 INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DEATH. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.NA

    Description of Event or Problem · 0

    THIS REPORT IS BEING CONSERVATIVELY FILED DUE TO PATIENT DEATH, UNKNOWN IF DEVICE RELATED.CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDYPATIENT ID: (B)(6)IT WAS REPORTED THAT ON 16-NOV-2021, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION (MR) GRADE 3+ WITH A SIGNIFICANT CLEFT/SCALLOP AND POSTERIOR LEAFLET PROLAPSE. ONE MITRACLIP (CDS0702-XTW, 10615R212) WAS IMPLANTED WITHOUT A DEVICE ISSUE, REDUCING THE MR TO GRADE 1+.THIS PATIENT WAS PREVIOUSLY CAPTURED IN E-131390 // CN-142233 (PREVIOUSLY FILED REPORT NUMBER 2135147-2022-02483-00) AS FOLLOWS [[[]]]:[[[ON (B)(6) 2022, THE PATIENT HAD BEEN HOSPITALIZED FOR HEART FAILURE. THE PATIENT HAS BEEN SUBSEQUENTLY DISCHARGED.THE EVENT IS UNKNOWN IF DEVICE RELATED. THERE WAS NO DEVICE MALFUNCTION REPORTED.]]]ON (B)(6) 2023, THE PATIENT HAD EXPIRED. THE CAUSE OF DEATH WAS NOT KNOWN. THERE REMAINED NO DEVICE MALFUNCTION REPORTED.REPORTEDLY, ADDITIONAL DETAILS WERE NOT AVAILABLE.NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876641 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 10615R212

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death