BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP XTR DELIVERY SYSTEM

    MDR report key: 7855608 · Received September 7, 2018

    Report

    Report Number
    2024168-2018-06952
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    July 20, 2018
    Report Date
    October 31, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT COULD NOT BE DETERMINED WHICH OF THE TWO CLIPS HAD THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). HOWEVER, BOTH CLIPS CAME FROM THE SAME LOT. THEREFORE, THE LOT HISTORY REVIEW (LHR) AND COMPLAINT HISTORY RISK ASSESSMENT APPLICABLE FOR BOTH IMPLANTED CLIPS, CDS0601-XTR/80412U2/51 AND CDS0601-XTR/80412U2/54 THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF WORSENING MITRAL REGURGITATION, DYSPNEA, HEART FAILURE, EDEMA, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, TREATMENT WITH MEDICATION AND HOSPITALIZATION AS LISTED IN THE MITRACLIP NT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) APPEARS TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY DUE TO HYPERMOBILE LARGE FLAIL. THE MITRAL REGURGITATION (MR) WAS LIKELY A RESULT OF THE SLDA AND THE DYSPNEA, HEART FAILURE AND EDEMA WERE CASCADING EFFECTS OF THE MR. 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 · 0

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ADDITIONAL INFORMATION OBTAINED: ON (B)(6) 2018 (INDEX MITRACLIP PROCEDURE), THE PATIENT PRESENTED WITH A P3 SEGMENT FLAIL. THE P3 WAS ALSO VERY FLOPPY LEAFLET AND WITH A LARGE GAP. ON (B)(6) 2018, THE PATIENT HAD SWELLING OF THE ANKLES, TREATED WITH MEDICATIONS. REPORTEDLY, BREATHING WAS BETTER POST PROCEDURE. WORSENING HEART FAILURE WAS DIAGNOSED AND A PARTIAL CLIP DETACHMENT WAS SUSPECTED. ON (B)(6) 2018, THORACIC ESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND THE IMPLANTED MITRACLIP HAD DETACHED FROM THE POSTERIOR LEAFLET WHILE REMAINING ATTACHED TO THE ANTERIOR LEAFLET, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). THE PATIENT REPORTED IMPROVEMENT IN BREATHING WITH MILD SHORTNESS OF BREATH. BILATERAL ANKLE SWELLING CONTINUED. THE EVENT DID NOT REQUIRE HOSPITALIZATION AND MEDICATIONS WERE TAKEN AS NEEDED. ON (B)(6) 2018, ANOTHER MITRACLIP PROCEDURE WAS PERFORMED. ANOTHER MITRACLIP WAS IMPLANTED, REDUCING THE MR TO MILD-MODERATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. TWO LOT NUMBERS WERE PROVIDED, 80412U251 AND 80412U254. THE LOT NUMBER OF THE CLIP ASSOCIATED WITH PARTIAL CLIP MOVEMENT WAS NOT DETERMINED. THE MITRACLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS REPORT IS FILED DUE TO PARTIAL CLIP DETACHMENT AND INCREASED MITRAL REGURGITATION. IT WAS REPORTED THAT ON (B)(6) 2018, A MITRACLIP PROCEDURE WAS PERFORMED, TREATING DEGENERATIVE MITRAL REGURGITATION (MR) GREATER THAN OR EQUAL TO 3+. TWO MITRACLIPS (CDS80412U251 AND CDS80412U254) WERE IMPLANTED WITHOUT REPORTED ISSUE, REDUCING THE MR TO GRADE 1+. ON (B)(6) 2018, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND MITRAL REGURGITATION (MR) GRADE 4+ WAS NOTED. ON (B)(6) 2018, ANOTHER TTE WAS PERFORMED. PER IMAGING, BOTH CLIPS REMAINED ON THE ANTERIOR AND POSTERIOR LEAFLETS. THE LATERAL MITRACLIP WAS SLIGHTLY DETACHED FROM THE POSTERIOR LEAFLET. THE SEVERE MR WAS NOTED FROM THE POSTERIOR 3 (P3) SEGMENT OF THE MITRAL VALVE AND IS DIRECTED ANTEROLATERALLY. THE MR JET DOES NOT APPEAR TO BE ORIGINATING FROM THE REGION OF THE PARTIALLY DETACHED MITRACLIP. REPORTEDLY, THE PARTIAL DETACHMENT IS POSSIBLY DUE TO THE HYPERMOBILE LARGE FLAIL. ANOTHER MITRACLIP PROCEDURE WILL BE SCHEDULED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698452 MITRACLIP XTR DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R 1 IMPLANTED MITRACLIP| ONE IMPLANTED MITRACLIP