BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 16418754 · Received February 22, 2023

    Report

    Report Number
    2135147-2023-00632
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 22, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT AND IMPLANT DATES ARE ESTIMATED. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART/LOT INFORMATION WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, A CAUSE FOR THE REPORTED PERFORATION RESULTING IN HYPOXIA CANNOT BE DETERMINED. HOWEVER, PERFORATION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT HYPOXIA AND ATRIAL SEPTAL DEFECT, REQUIRING CLOSURE. IT WAS REPORTED IN AN ARTICLE THAT THE PATIENT UNDERWENT A MITRACLIP PROCEDURE TO TREAT SEVERE FUNCTIONAL MITRAL REGURGITATION (MR). ONE XTR CLIP WAS IMPLANTED BETWEEN A3/P3, REDUCING MR TO MILD. AFTER THE PROCEDURE, THE PATIENT SUFFERED ABRUPT OXYGEN DESATURATION. ECHOCARDIOGRAM REVEALED A RIGHT-TO-LEFT SHUNT THROUGH AN IATROGENIC ATRIAL SEPTAL DEFECT. IT WAS SUCCESSFULLY CLOSED WITH A 12-MM AMPLATZER SEPTAL OCCLUDER. SHOWING AN IMMEDIATE HEMODYNAMIC IMPROVEMENT. SIX MONTHS LATER, THE PATIENT CONTINUED WITH RIGHT HEART FAILURE. RIGHT HEART CATHETERIZATION REVEALED A MEAN PULMONARY ARTERY PRESSURE OF 34 MM HG AND A RIGHT ATRIAL PRESSURE OF 21 MM HG (V-WAVE OF 30). AN INTERVENTIONAL HETEROTOPIC TRICUSPID VALVE IMPLANTATION WAS PLANNED BASED ON COMPUTED TOMOGRAPHY. TWO TRICVALVE SELF-EXPANDING BIOLOGICAL VALVES (P+F) WERE SUCCESSFULLY IMPLANTED PERCUTANEOUSLY. AT 24-MONTH FOLLOW-UP EXAM, THE PATIENT SHOWED NEW YORK HEART ASSOCIATION CLASS II, IMPROVEMENT IN THE 6-MINUTE WALK TEST (248 TO 370 METERS) AND REDUCTION IN TR. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE LISTED IN THE ARTICLE TITLED, ¿THREE DEVICES IN ONE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407829 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention