BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 15987916 · Received December 15, 2022

    Report

    Report Number
    2135147-2022-02565
    Event Type
    Death
    Date Received
    December 15, 2022
    Date of Event
    November 8, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) REVIEW WAS NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION, THE REPORTED TISSUE INJURY APPEARS TO BE DUE TO PROCEDURAL CIRCUMSTANCES. THE REPORTED CARDIOGENIC SHOCK WAS DUE TO THE TISSUE INJURY. A CAUSE OF THE REPORTED RENAL FAILURE (KIDNEY DYSFUNCTION) COULD NOT BE DETERMINED. THE REPORTED DEATH APPEARS TO BE DUE TO RENAL FAILURE. THE REPORTED PATIENT EFFECT OF TISSUE INJURY, CARDIOGENIC SHOCK, RENAL FAILURE AND DEATH AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND MEDICATION REQUIRED WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. DATES ESTIMATED. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ATTACHMENT: ARTICLE TITLED, "ASSESSMENT OF THE MITRACLIP PROCEDURE: REASSESSING THE GOALS".

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE THAT THE PATIENT UNDERWENT A MITRACLIP PROCEDURE TO TREAT A SEVERE MITRAL REGURGITATION (MR). USING TEE GUIDANCE, THE MITRACLIP DEVICE WAS POSITIONED AND ADVANCED ACROSS THE MITRAL VALVE LEAFLETS. PLACEMENT OF AN NTW CLIP REDUCED THE MR FROM SEVERE TO MODERATE ECHOCARDIOGRAPHIC COLOR DOPPLER IMAGING REVEALED, WHAT WAS DESCRIBED AS A ¿PROMINENT¿ REGURGITANT JET MEDIAL TO THE FIRST CLIP. A SECOND CLIP WAS ATTEMPTED MEDIALLY TO THE FIRST BUT CAUSED SIGNIFICANT LEAFLET TRAUMA TO THE ANTERIOR LEAFLET RESULTING IN SEVERE MITRAL REGURGITATION AND CARDIOGENIC SHOCK. RESUSCITATION INCLUDED INFUSIONS OF EPINEPHRINE, NOREPINEPHRINE, VASOPRESSIN, AND PLACEMENT OF AN INTRA-AORTIC BALLOON PUMP. SUBSEQUENTLY, AN XTW CLIP WAS PLACED MEDIAL TO THE FIRST MITRACLIP REDUCING THE MITRAL REGURGITATION FROM SEVERE TO MILD/MODERATE. A LARGE IATROGENIC ATRIAL SEPTAL DEFECT WAS CLOSED WITH AN AMPLATZER CLOSURE DEVICE. DESPITE A REDUCTION OF MITRAL REGURGITATION, RIGHT VENTRICULAR FAILURE PERSISTED REQUIRING CONTINUED VASOACTIVE MEDICATIONS. KIDNEY FUNCTION WORSENED AND THE PATIENT EXPIRED 4 DAYS AFTER THE MITRACLIP PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, ¿ASSESSMENT OF THE MITRACLIP PROCEDURE: REASSESSING THE GOALS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439171 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death