BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP XTR DELIVERY SYSTEM

    MDR report key: 8670191 · Received June 5, 2019

    Report

    Report Number
    2024168-2019-04415
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 5, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE THROMBOSIS COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL MITRACLIP DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THROMBOSIS. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS SUCCESSFULLY IMPLANTED. THE SECOND CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE LEFT ATRIUM. WHILE INSIDE THE LEFT ATRIUM, THROMBUS WAS OBSERVED ON THE TIP OF THE STEERABLE GUIDE CATHETER (SGC). THE CDS WAS REMOVED AND ASPIRATION WAS PERFORMED TO REMOVE THE THROMBUS FROM THE SGC TIP. THE CDS WAS CAREFULLY EXAMINED, CLEANED WITH HEPARINIZED SALINE AND RE-INSERTED INTO THE SGG. AFTER THE CDS REACHED THE LEFT ATRIUM, THROMBUS IMMEDIATELY FORMED ON THE TIP OF THE CLIP. THE CLIP WAS NOT IMPLANTED AND THE CDS WAS REMOVED WITH THE THROMBUS MATERIAL. A NEW CDS WAS USED AND THE CLIP WAS IMPLANTED AND NO FURTHER THROMBUS WAS OBSERVED. THREE CLIPS WERE IMPLANTED, REDUCING MR TO 1-2. THE ACTIVATED COAGULATION TIME (ACT) FLUCTUATED BETWEEN 180 TO 350 DURING THE PROCEDURE DESPITE MEASURING EVERY 20 MINUTES, AND ADMINISTERING HEPARIN ACCORDING TO NORMAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464078 MITRACLIP XTR DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 90212U188

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other STEERABLE GUIDE CATHETER, 1 IMPLANTED MITRACLIP