BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6157001 · Received December 8, 2016

    Report

    Report Number
    2024168-2016-08741
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 29, 2016
    Report Date
    January 25, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE CLIP DELIVERY SYSTEM WAS DISCARDED. THE CLIP REMAINS IN THE ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. ALL AVAILABLE INFORMATION WAS INVESTIGATED THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) APPEARS TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY. THE REPORTED MITRAL REGURGITATION WAS LIKELY A RESULT OF THE SLDA. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS FILED BECAUSE 7 DAYS POST-PROCEDURE, THE IMPLANTED CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. IT WAS REPORTED THAT THE MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 1. ON (B)(6) 2016, DURING A FOLLOW UP VISIT, A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED, WHICH FOUND THAT THE CLIP HAD DETACHED FROM THE POSTERIOR MITRAL VALVE LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). MR RETURNED TO 4. THE PATIENT IS STABLE. A SECOND MITRACLIP PROCEDURE IS TO BE SCHEDULED, (EXACT DATE HAS NOT BEEN SCHEDULED) TO STABILIZE THE SLDA CLIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804685 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60613U226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other