BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP NTR CLIP DELIVERY SYSTEM

    MDR report key: 12037332 · Received June 21, 2021

    Report

    Report Number
    2024168-2021-05228
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 31, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 INCIDENT REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION, THE REPORTED DEVICE DAMAGED BY ANOTHER DEVICE-CAUSED DAMAGE APPEARS TO BE RELATED TO USER TECHNIQUE/PROCEDURAL CIRCUMSTANCES. ADDITIONALLY, REPORTED DIFFICULT TO REMOVE APPEARS TO BE DUE TO PROCEDURAL CONDITION (CONTACT BETWEEN THE CLIP). THERE IS NO INDICATION OF 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 THE ADDITIONAL CLIP DELIVERY SYSTEM DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE CLIP ENTANGLEMENT. IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 4. THE STEERABLE GUIDE CATHETER (SGC) WAS INSERTED AND THE FIRST XTR MITRACLIP DELIVERY SYSTEM (CDS) WAS IMPLANTED MEDIAL. TO FURTHER REDUCE MR, A SECOND CLIP (XTR 01130U181) WAS IMPLANTED LATERAL WITHOUT ISSUE. AN NTR CLIP (NTR 00821U111), WAS ADVANCED TO BE IMPLANTED BETWEEN THE TWO XTR CLIPS. HOWEVER, THE NTR CLIP GOT STUCK IN THE SECOND IMPLANTED XTR CLIP (01130U181), CAUSING THE XTR CLIP TO PARTIALLY MOVE FROM THE ANTERIOR LEAFLET BUT STILL REMAINED ON BOTH LEAFLETS. AFTER SOME MOVEMENTS THE NTR CLIP WAS FREED; HOWEVER, THE XTR CLIP (01130U181) DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET/SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). THE NTR CLIP WAS IMPLANTED, STABILIZING THE SLDA CLIP. MR WAS REDUCED 1-2. 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
    932691 MITRACLIP NTR CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR 00821U111

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED MITRACLIP(X1)| STEERABLE GUIDE CATHETER