BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 8663231 · Received June 3, 2019

    Report

    Report Number
    2024168-2019-04301
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 3, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648216800
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF WORSENING MITRAL REGURGITATION, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED MITRAL REGURGITATION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. MITRACLIP NTR (CDS0601-NTR/81004U226) REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT RECURRENT MR REQUIRING MEDICAL INTERVENTION. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2018, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS (CDS0501/80316U275 AND CDS0501/80308U243) WERE SUCCESSFULLY IMPLANTED REDUCING MR TO 1-2. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH AN INCREASE IN MR TO 4. BOTH MITRACLIPS REMAINED STABLE ON BOTH LEAFLETS. ON (B)(6) 2019, A SECOND MITRACLIP PROCEDURE WAS PERFORMED. ONE MITRACLIP NTR WAS SUCCESSFULLY IMPLANTED. A SECOND MITRACLIP NTR (CDS0601-NTR/81004U226) WAS ADVANCED AND IMPLANTED MEDIAL TO THE THREE CLIPS, HOWEVER A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED. THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET. POST PROCEDURE MR WAS REDUCED TO 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456165 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 80308U243 08717648216800

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R 1 IMPLANTED MITRACLIP