BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 5071343 · Received September 11, 2015

    Report

    Report Number
    2024168-2015-05281
    Event Type
    Death
    Date Received
    September 11, 2015
    Date of Event
    August 19, 2015
    Report Date
    October 1, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP. THE CUSTOMER REPORTED THE CLIP DELIVERY SYSTEM WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS AND INFORMATION PROVIDED TO ABBOTT VASCULAR. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). THE REPORTED PATIENT EFFECTS OF DEATH, WORSENING MITRAL REGURGITATION (MR), MITRAL VALVE INJURY (TISSUE DAMAGE), AND CARDIOGENIC SHOCK, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THAT DURING LEAFLET GRASPING OF THE SECOND CLIP (50304U142), POSTERIOR LEAFLET TEAR AND INCREASED MITRAL REGURGITATION OCCURRED, RESULTING IN SURGERY AND DEATH DUE TO CARDIOGENIC SHOCK. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE PATIENT EXPERIENCED ACUTE MYOCARDIAL INFARCTION 2 WEEKS PRIOR TO MITRACLIP PROCEDURE WITH ONGOING PULMONARY EDEMA. THE FIRST CLIP DELIVERY SYSTEM (CDS 50304U143) WAS ADVANCED TO THE MITRAL VALVE AND THE CLIP WAS IMPLANTED WITH GOOD LEAFLET INSERTION. THE MR WAS REDUCED TO 2-3 WITH RESIDUAL MR LATERAL TO THE IMPLANTED CLIP. THE SECOND CDS (50304U142) WAS ADVANCED AND THE CLIP WAS POSITIONED ON THE LEAFLETS WITH A REDUCTION IN MR BELOW 1. DURING LEAFLET ASSESSMENT, THE MR INCREASED TO 4. ECHOCARDIOGRAM WAS PERFORMED AND IT WAS OBSERVED THAT THE POSTERIOR LEAFLET WAS TORN LATERAL TO THE SECOND CLIP. THE CLIP WAS OPENED AND THE CDS AND CLIP WERE REMOVED. THE PATIENT WAS TREATED WITH AN INTRA-AORTIC BALLOON PUMP AND IMMEDIATELY TRANSFERRED TO SURGERY DUE TO THE SEVERITY OF THE MR AND LEAFLET TEAR; HOWEVER, THE PATIENT DIED FOLLOWING SURGERY. IT WAS NOTED THAT THE CARDIAC SURGEON OBSERVED THAT THE LEAFLET WAS VERY FRAGILE AND THERE WERE SIGNS OF PERICARDITIS. THE CAUSE OF DEATH WAS REPORTED AS CARDIOGENIC SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601289 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 50304U142

    Patients

    Seq Age Sex Outcome Treatment
    1 Death