BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM NTW US

    MDR report key: 10564084 · Received September 21, 2020

    Report

    Report Number
    2024168-2020-07885
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 22, 2020
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT/SLDA IS THE RESULT OF PATIENT ANATOMY, AS TETHERED AND RESTRICTED LEAFLETS WERE NOTED. THE REPORTED ADDITIONAL MITRACLIP IMPLANTATION IS THE RESULT OF CASE SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT/SLDA AND MEDICAL INTERVENTION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. IT WAS NOTED TETHERING AND RESTRICTED LEAFLETS. DURING PREPARATION OF THE FIRST CLIP DELIVERY SYSTEM (CDS 00326U172), THE CLIP OPENED WHILE LOCKED WHEN ESTABLISHING FINAL ARM ANGLE/EFAA. THE CLIP WAS NOT USED IN THE PATIENT, AND THE PROCEDURE CONTINUED WITH A NEW CLIP (00326U172). THE CLIP WAS DEPLOYED; HOWEVER, THE CLIP BECAME DETACHED FROM THE ANTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE PHYSICIAN STATED THE SLDA WAS DUE TO THE PATIENT¿S ANATOMY. AN ADDITIONAL CLIP WAS DEPLOYED TO STABILIZE THE SLDA. TWO CLIPS WERE IMPLANTED, REDUCING MR TO 2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024638 MITRACLIP G4 CLIP DELIVERY SYSTEM NTW US MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-NTW 00326U173 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention STEERABLE GUIDE CATHETER