BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15363025 · Received September 6, 2022

    Report

    Report Number
    2135147-2022-01009
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 25, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648230943
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE NTW MITRACLIP REPORTED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, A CAUSE FOR THE REPORTED UNSPECIFIED TISSUE INJURY CANNOT BE DETERMINED. UNSPECIFIED TISSUE INJURY IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THIS IS BEING FILED TO REPORT A CHORDAL RUPTURE. IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND WAS A 2 YEAR POST-OPERATIVE HEART TRANSPLANT RECIPIENT. AN NTW MITRACLIP WAS SUCCESSFULLY IMPLANTED. A SECOND CLIP, AN NT, WAS POSITIONED MEDIAL TO THE FIRST CLIP. ON THE MEDIAL SIDE OF THE NTW, A CHORD WAS RUPTURED. SHORTLY AFTER, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED WITH THE NTW. THE POSTERIOR LEAFLET WAS DETACHED FROM THE NTW. THE SECOND AND THIRD CLIP WEREUSED TO STABILIZE THE FIRST CLIP. THERE WAS NO ADVERSE PATIENT SEQUELAE OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587949 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0701-NT 11014R155 08717648230943

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other MITRACLIP| STEERABLE GUIDE CATHETER