BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15658522 · Received October 24, 2022

    Report

    Report Number
    2135147-2022-01752
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    September 29, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648230967
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) APPEARS TO BE DUE TO CHALLENGING ANATOMY (THIN LEAFLET) WITH POOR VISUALIZATION (HEAVY SHADOWING ON THE ANTERIOR LEAFLET). THE REPORTED POOR IMAGE RESOLUTION WAS DIFFICULT TO VISUALIZE DUE TO HEAVY SHADOWING ON THE ANTERIOR LEAFLET. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND SERIOUS INJURY/ ILLNESS/ IMPAIRMENT WAS THE 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 A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND INTERVENTION. IT WAS REPORTED A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) WITH POSTERIOR PROLAPSE, VERY THIN LEAFLETS AND HEAVY SHADOWING ON THE ANTERIOR LEAFLET. THE FIRST NTW CLIP ((B)(4)) WAS PLACED CENTRALLY AT A2/P2. EXTENDED TIME WAS UTILIZED TO CONFIRM LEAFLET INSERTION, INCLUDING X-PLANE OFF OF BICOM, MULTIPLE LONG AXIS VIEWS, TG SAX, LIVE 3D AND 3D ENFACE TO CONFIRM ADEQUATE LEAFLET INSERTION. THE MR WAS REDUCED FROM 4+ TO 2+. THE PHYSICIAN DECIDED TO PLACE ANOTHER CLIP JUST LATERAL TO THE FIRST ONE. UPON DEPLOYMENT, THE CLIP IMMEDIATELY DETACHED FROM THE ANTERIOR LEAFLET RESULTING IN A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). THE CLIP REMAILED ATTACHED TO THE POSTERIOR LEAFLET AND APPEARED VERY STABLE. AN XTW WAS PREPARED AND PLACED ON THE LATERAL ASPECT OF THE SLDA IN THE A2/P2 REGION. MR WAS REDUCED FROM 4+ TO 1+. THERE WAS NO DELAY IN THERAPY. THE FOLLOWING DAY, A TRANSTHORACIC ECHOCARDIOGRAM SHOWED TRACE MR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591405 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL CDS0701-NTW 11007R146 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention STEERABLE GUIDE CATHETER AND MITRACLIP