BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 18950815 · Received March 21, 2024

    Report

    Report Number
    2135147-2024-01282
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 28, 2024
    Report Date
    April 18, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED HEMORRHAGE, RENAL FAILURE, HEART FAILURE, AND DEATH. HEMORRHAGE, RENAL FAILURE, HEART FAILURE, AND DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTIONS WERE RESULTS OF CASE SPECIFIC CIRCUMSTANCES. THE REPORTED OFF-LABEL USE WAS DUE TO THE DEVICE BEING USED ON A TRICUSPID VALVE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLED, "SAME-DAY DISCHARGE FOLLOWING ELECTIVE TRANSCATHETER EDGE-TO-EDGE REPAIR".

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ATTACHMENT: ARTICLE TITLED "SAME-DAY DISCHARGE FOLLOWING ELECTIVE TRANSCATHETER EDGE-TO-EDGE REPAIR."

    Description of Event or Problem · 0

    THIS RESEARCH ARTICLE WAS A RETROSPECTIVE STUDY DESIGNED TO EVALUATE THE OUTCOMES AFTER SAME-DAY DISCHARGE (SDD) IN PATIENTS WHO UNDERWENT TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER). COMPLICATIONS IDENTIFIED IN THE STUDY INCLUDED: SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), LIFE-THREATENING BLEEDING, VASCULAR COMPLICATION, ACUTE KIDNEY INJURY, MITRAL OR TRICUSPID REINTERVENTION, READMISSION DUE TO HEART FAILURE, AND ALL-CAUSE MORTALITY. IN CONCLUSION, IN THIS SINGLE-CENTER RETROSPECTIVE ANALYSIS, SDD AFTER TEER WAS FEASIBLE WITH COMPARABLE SAFETY OUTCOMES WITH NON-SDD. PATIENTS UNDERGOING ISOLATED TTEER, COMBINED MITRAL AND TRICUSPID TEER, OR AFTERNOON PROCEDURES WERE MORE LIKELY TO HAVE A DELAYED DISCHARGE (>1 DAY). AS TEER CONTINUES TO BECOME WIDELY ADOPTED, THE SDD PATHWAY IS LIKELY TO BE MORE COMMONLY IMPLEMENTED. A LARGER PROSPECTIVE STUDY IS ONGOING TO FURTHER EVALUATE THE SAFETY AND EFFICACY OF THE SDD APPROACH. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, "SAME-DAY DISCHARGE FOLLOWING ELECTIVE TRANSCATHETER EDGE-TO-EDGE REPAIR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747817 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| R| D| H| L