BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6170561 · Received December 13, 2016

    Report

    Report Number
    2024168-2016-08823
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 13, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648156199
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). . CONCOMITANT PRODUCTS: MITRACLIP SYSTEM, STEERABLE GUIDING CATHETER, 1 ADDITIONAL MITRACLIP IMPLANTED. 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. THE REPORTED PATIENT EFFECTS OF MITRAL VALVE INJURY (TISSUE DAMAGE) AND WORSENING MR, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED DIFFICULTY GRASPING APPEARS TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY. THE REPORTED TISSUE DAMAGE (LEAFLET) TEAR AND SUBSEQUENT WORSENING MR WAS LIKELY RELATED TO PATIENT/PROCEDURAL CONDITIONS; THE PATIENT CONTINUED TO HAVE SEVERE MITRAL INSUFFICIENCY AFTER THE TWO CLIPS WERE SUCCESSFULLY IMPLANTED AND THE TEAR WAS LIKELY DUE TO THE IMPLANTED CLIP. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE SEVERE MITRAL INSUFFICIENCY AND THE POSTERIOR LEAFLET TEAR, REQUIRING INTERVENTION. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS ((B)(4)) WERE IMPLANTED IN A2/P2, REDUCING THE MR TO 3. IT WAS NOTED THAT APPROXIMATELY 20 GRASPS WERE NEEDED WITH THE SECOND CLIP ((B)(4)) DUE TO THE CHALLENGING LEAFLET ANATOMY. AFTER THE MITRACLIP PROCEDURE, IT WAS OBSERVED THAT THE PATIENT STILL HAD SEVERE MITRAL INSUFFICIENCY WITH DECOMPENSATION AND NEEDED AN INTRA-AORTIC BALLOON PUMP. IT WAS CONFIRMED THAT THE 2 IMPLANTED CLIPS WERE SECURE ON THE LEAFLETS. THE PATIENT UNDERWENT SUCCESSFULLY SURGERY ON (B)(6) 2016. A POSTERIOR LEAFLET TEAR (P3) WAS OBSERVED AT THE CLEFT, NEAR THE SECOND CLIP ((B)(4)). THE PATIENT REMAINS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822747 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 51112U157 08717648156199

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R| S