BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 15481627 · Received September 24, 2022

    Report

    Report Number
    2135147-2022-01361
    Event Type
    Death
    Date Received
    September 24, 2022
    Date of Event
    September 1, 2015
    Report Date
    October 21, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DATES ESTIMATED. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ATTACHMENT: ARTICLE TITLED, "ACUTE KIDNEY INJURY FOLLOWING TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR".

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) AND SIMILAR INCIDENT REVIEWS WERE NOT PERFORMED BECAUSE NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE DEATHS WERE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT DEATH. THIS RESEARCH ARTICLE WAS A RETROSPECTIVE STUDY DESIGNED TO INVESTIGATE THE PROGNOSTIC IMPACT OF POSTPROCEDURAL ACUTE KIDNEY INJURY (AKI) FOLLOWING TRANSCATHETER EDGE-TO-EDGE VALVE REPAIR (TEER) FOR TRICUSPID REGURGITATION (TR). COMPLICATIONS IDENTIFIED IN THE STUDY INCLUDED: SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), HOSPITALIZATION, HEART FAILURE, MEDICAL INTERVENTION, RENAL FAILURE, HEMORRHAGE, DEATH. IN CONCLUSION, POSTPROCEDURAL AKI OCCURRED IN 15.7% OF PATIENTS UNDERGOING TEER FOR TR, DESPITE THE ABSENCE OF IODINATED CONTRAST AGENTS, WHICH WAS ASSOCIATED WITH WORSE CLINICAL OUTCOMES. THESE FINDINGS HIGHLIGHT THE CLINICAL IMPACT OF AKI FOLLOWING TEER FOR TR AND SHOULD HELP IN IDENTIFYING PATIENTS AT HIGH RISK FOR AKI. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, " ACUTE KIDNEY INJURY FOLLOWING TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700345 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death