BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP NTR CLIP DELIVERY SYSTEM

    MDR report key: 10284217 · Received July 16, 2020

    Report

    Report Number
    2024168-2020-05894
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 26, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648226342
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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, THE REPORTED TISSUE DAMAGE APPEARS TO BE A CAUSE OF PROCEDURAL CIRCUMSTANCES/ USER TECHNIQUE. THE REPORTED PATIENT EFFECT OF MITRAL VALVE INJURY (TISSUE DAMAGE) AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH GRADE 4+. THE FIRST NTR CLIP DELIVERY SYSTEM (CDS) (CDS0601-NTR, 00120U251) WAS ADVANCED TO THE MITRAL VALVE AND GRASPING WAS PERFORMED WITHOUT ISSUE BUT MR COULD NOT BE REDUCED. THEREFORE, IT WAS DECIDED NOT TO IMPLANT THE CLIP AND CHANGE IT TO AN XTR CLIP. THE XTR CDS (CDS0601-XTR, 00109U168) WAS ADVANCED TO THE MITRAL VALVE AND THE CLIP WAS IMPLANTED, REDUCING MR. AN NTR CDS (CDS0601-NTR, 91212U417) WAS THEN ADVANCED TO FURTHER REDUCE MR, AND WHEN GRASPING WAS PERFORMED, MR INCREASED. ECHOCARDIOGRAM SHOWED THAT THE POSTERIOR LEAFLET WAS TEARING WITH EACH GRASP FROM THE NTR CLIP. IT APPEARED AS THE POSTERIOR LEAFLET WAS DISINTEGRATING. THE NTR CDS WITH CLIP WAS REMOVED. THERE WAS NO ISSUE WITH GRASPING. THE XTR CLIP REMAINED STABLE BUT MR HAD RETURNED TO 4+. IT WAS DECIDED TO SEND THE PATIENT TO SURGERY FOR MITRAL VALVE REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751065 MITRACLIP NTR CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR CDS0601-NTR 91212U417 08717648226342

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R| S