BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP XTR CLIP DELIVERY SYSTEM

    MDR report key: 11039758 · Received December 18, 2020

    Report

    Report Number
    2024168-2020-10711
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 8, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS LOT AND PART NUMBERS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, A CAUSE FOR THE REPORTED PERICARDIAL EFFUSION COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF PERICARDIAL EFFUSION IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE AND IS A KNOWN POSSIBLE COMPLICATION OF MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    DATES OF EVENT, TESTS, AND IMPLANT: DATES ESTIMATED. (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI NUMBER CANNOT BE CALCULATED. THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ARTICLE TITLED EXPEDITED MITRA CLIP: RAPID EVALUATION, TREATMENT, AND DISCHARGE IN THE COVID-19 ERA.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT A TRIVIAL PERICARDIAL EFFUSION WAS NOTED. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP USED IN A (B)(6) YEAR-OLD MALE WITH FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE 4. TWO CLIPS WERE IMPLANTED SUCCESSFULLY WITHOUT ANY COMPLICATIONS, REDUCING MR TO 1. POST-PROCEDURE ECHOCARDIOGRAM REVEALED MILD MR, MEAN MV GRADIENT OF 3 MMHG, AND TRIVIAL PERICARDIAL EFFUSION. THE PATIENT WAS TRANSFERRED TO THE CATHETERIZATION LABORATORY RECOVERY AREA. A REPEAT EKG WAS DONE AFTER 4-HOUR POST-PROCEDURE, AND NO CHANGES WERE NOTED. BEDSIDE TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) CONFIRMED CLIP PLACEMENT WITH NO EVIDENCE OF PERICARDIAL EFFUSION; THE PATIENT WAS SUBSEQUENTLY AMBULATED. AFTER CONFIRMING EACH OF THESE MILESTONES, THE PATIENT WAS SET UP FOR SAME DAY DISCHARGE (SDD). DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED EXPEDITED MITRA CLIP: RAPID EVALUATION, TREATMENT, AND DISCHARGE IN THE COVID-19 ERA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504889 MITRACLIP XTR CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other