BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19614188 · Received June 26, 2024

    Report

    Report Number
    2135147-2024-03020
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED. ATTACHMENT: ARTICLE TITLED "INDICATIONS AND OUTCOMES OF THE MITRACLIP G4 DEVICE WITH CONTROLLED GRIPPER ACTUATION SYSTEM¿.

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW. A REVIEW OF THE LOT HISTORY RECORD AND A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW, AND LOT/DEVICE INFORMATION IS NOT AVAILABLE. BASED ON AVAILABLE INFORMATION, THE REPORTED DIFFICULT OR DELAYED POSITIONING (LEAFLET CAPTURE AND LEAFLET GRASPING) APPEAR TO BE RELATED TO PROCEDURAL CONDITIONS (UNCLEAR LEAFLET INSERTION AND/OR COMPLEX MITRAL VALVE ANATOMY). A CAUSE FOR THE REPORTED INCOMPLETE COAPTATION COULD NOT BE CONCLUSIVELY DETERMINED. CAUSES FOR THE REPORTED MITRAL REGURGITATION, HEART FAILURE, AND DEATH COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, MITRAL REGURGITATION, HEART FAILURE, AND DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS OF MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND SURGICAL INTERVENTION WERE THE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE ADDITIONAL PATIENT EFFECT OF DEATH AND MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLE ¿INDICATIONS AND OUTCOMES OF THE MITRACLIP G4 DEVICE WITH CONTROLLED GRIPPER ACTUATION SYSTEM¿.

    Description of Event or Problem · 0

    THE ARTICLE, ¿INDICATIONS AND OUTCOMES OF THE MITRACLIP G4 DEVICE WITH CONTROLLED GRIPPER ACTUATION SYSTEM¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY. THE ARTICLE CONCLUDED THAT INDICATIONS OF CGA DURING THE TEER PROCEDURE CAN BE DIVIDED INTO (1) CGA FOR GRASPING AND (2) CGA FOR CONFIRMATION OF LEAFLET INSERTION. IN PATIENTS WITH COMPLEX MITRAL VALVE ANATOMY, CGA MAY BE A SAFE AND EFFECTIVE METHOD FOR CONFIRMING LEAFLET INSERTION. IT SHOULD BE NOTED THAT WHEN USING CGA FOR LEAFLET GRASPING, ESPECIALLY WHEN THE CLIP IS MOVED SIGNIFICANTLY, ATTENTION SHOULD BE PAID TO LEAFLET ADVERSE EVENTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS (B)(6)]. THE TIME FRAME OF THE STUDY WAS 01SEPTEMBER2020 TO 31JULY2023. A TOTAL OF 158 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE FOR MITRAL VALVE REPAIR. THE AVERAGE AGE OF THE PATIENTS ENROLLED WAS 80. THE MAJORITY GENDER WAS MALE. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDED DIABETES, ATRIAL FIBRILLATION, MITRAL REGURGITATION, TRICUSPID REGURGITATION, HYPERTENSION, DYSLIPIDEMIA, CHRONIC KIDNEY DISEASE, HEMODIALYSIS, PREVIOUS MITRAL VALVE SURGERY. PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HOSPITALIZATION, SURGICAL INTERVENTION, RECURRENT MR, HEART FAILURE, TISSUE DAMAGE, SINGLE LEAFLET DEVICE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626276 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H