BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 14060087 · Received April 8, 2022

    Report

    Report Number
    2024168-2022-03822
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 18, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648230967
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    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 THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS FROM THE LOT. THE REPORTED PATIENT EFFECT OF TISSUE DAMAGE IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND A CAUSE FOR THE UNINTENDED MOVEMENT ASSOCIATED WITH THE CLIP ROTATING CANNOT BE DETERMINED. THE REPORTED IMAGE RESOLUTION POOR APPEARS TO BE RELATED TO PROCEDURAL CIRCUMSTANCES AS IT WAS REPORTED THAT IMAGING WAS DIFFICULT DUE TO IMAGING QUALITY. A CAUSE FOR THE UNSPECIFIED TISSUE INJURY CANNOT BE DETERMINED. THE 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 UNINTENDED MOVEMENT AND TISSUE INJURY. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4, WITH PROLAPSE AND FLAIL. THE POSTERIOR LEAFLET WAS APPROXIMATELY 1.5CM, THE ANTERIOR-POSTERIOR DIMENSION WAS 30MM AND THE PATIENT HAD REDUNDANT LEAFLETS. REPORTEDLY, DURING THE PROCEDURE, THERE WAS DIFFICULTY IN IMAGING. THE NTW MITRACLIP DELIVERY SYSTEM ADVANCED AND THE CLIP WAS CAREFULLY ORIENTED IN THE LEFT ATRIUM (LA), AT THE INTENDED SITE OF IMPLANTATION. AFTER ORIENTATION THE CLIP DELIVERY SYSTEM (CDS) ADVANCED INTO THE LEFT VENTRICLE (LV). UPON OPENING THE CLIP, THE CLIP APPEARED SIGNIFICANTLY ROTATED (TURNED COUNTERCLOCKWISE) RELATIVE TO THE CLIP ORIENTATION PERFORMED IN THE LA. THE NTW MITRACLIP WAS INVERTED AND RETRACTED INTO THE LA, WITHOUT APPARENT RESISTANCE. REPOSITIONING AND RE-ORIENTATION WAS PERFORMED IN THE LA. TWO MORE ATTEMPTS WERE PERFORMED, ADVANCING THE NTW CDS INTO THE LV. ON THE FOURTH ATTEMPT, THE NTW MITRACLIP HAD MINIMAL ROTATION ONCE IN THE LV. SMALL CORRECTIONS TO THE ORIENTATION WERE PERFORMED IN THE LV, WITH NO CHORDAE ENTANGLEMENT OBSERVED. THE NTW MITRACLIP WAS ABLE TO GRASP AND CAPTURE THE LEAFLETS WITHOUT A DEVICE ISSUE, HOWEVER, THE LEAFLETS WERE REDUNDANT AND THERE WAS TOO MUCH LEAFLET OUTSIDE OF THE CLIP. REPORTEDLY, THERE WAS NO DIFFICULTY GRASPING OR CAPTURING THE LEAFLETS, HOWEVER, ONCE THE LEAFLETS WERE GRASPED, THE RESULTING MR REDUCTION WAS UNSATISFACTORY. THE NTW MITRACLIP WAS NOT DEPLOYED AND REMOVED FROM THE ANATOMY. UPON REMOVAL OF THE NTW, IT WAS NOTICED THAT THERE WAS A NEW, SIGNIFICANT FLAIL ORIGINATING FROM WHERE THE NTW MITRACLIP PLACEMENT WAS ATTEMPTED. TWO XTW CLIPS WERE SUCCESSFULLY IMPLANTED, REDUCING MR TO GRADE 1-2. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149352 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-NTW 11013R225 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Male Required Intervention STEERABLE GUIDE CATHETER