BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP NTR DELIVERY SYSTEM

    MDR report key: 8345698 · Received February 15, 2019

    Report

    Report Number
    2024168-2019-01166
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 15, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648226342
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 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. REVIEW OF THE COMPLAINT HISTORY REVEALED NO INDICATION OF A LOT SPECIFIC PRODUCT ISSUE. IT IS LIKELY THAT THE PATIENT ANATOMY CONTRIBUTED TO THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (INCOMPLETE COAPTATION). THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THAT ON (B)(6) 2018 TWO MITRACLIPS NTS WERE IMPLANTED IN THE PATIENT WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), REDUCING MR GRADE TO TRACE. ON (B)(6) 2019 THE PATIENT UNDERWENT A SECOND MITRACLIP PROCEDURE FOR RECURRENT MR GRADE 4 DUE TO DISEASE PROGRESSION. THE TWO ORIGINAL MITRACLIP NTS WERE STABLE AND ATTACHED TO BOTH LEAFLETS. AT THE RECLIP PROCEDURE, THE MITRACLIP NTR WAS IMPLANTED REDUCING MR TO GRADE 3 WITHOUT INCIDENT. DURING GRASPING WITH THE SECOND MITRACLIP NTR, THE FIRST NTR HAD A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) ; THERE WAS NO CONTACT WITH THE TWO NTR CLIPS. THE SECOND NTR WAS IMPLANTED SUCCESSFULLY TO BOTH STABILIZE THE SLDA CLIP AND REDUCE MR GRADE TO 2-3. ALTHOUGH THERE WAS NO ADVERSE PATIENT SEQUELA, THE PATIENT WILL UNDERGO AN ELECTIVE MITRAL VALVE SURGERY IN THE FUTURE FOR FURTHER MR REDUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136921 MITRACLIP NTR DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 81212U204 08717648226342

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention STEERABLE GUIDE CATHETER2 MITRACLIP NTS