BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP XTR CLIP DELIVERY SYSTEM

    MDR report key: 14594835 · Received June 3, 2022

    Report

    Report Number
    2024168-2022-05945
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE MITRACLIP NTR REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED 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 UNCHANGED MITRAL REGURGITATION (MR), TISSUE INJURY AND HEART FAILURE AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON AVAILABLE INFORMATION, A CAUSE OF THE REPORTED INCOMPLETE COAPTATION (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA) COULD NOT BE DETERMINED. THE REPORTED UNSPECIFIED TISSUE INJURY (CHORDAL INJURY, LEAFLET FLAIL) WAS DUE TO THE SLDA. THE REPORTED UNCHANGED MR WAS RELATED TO THE SLDA AND THE REPORTED HEART FAILURE WAS DUE TO THE UNCHANGED MR. THE REPORTED DELAY TO TREATMENT/ THERAPY WAS ASSOCIATED WITH THE SLDA. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT WITH TISSUE INJURY, REQUIRING ADDITIONAL HOSPITALIZATION. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION (MR) GRADE 4+, A DILATED LEFT ATRIUM, THIN LEAFLETS, POSTERIOR LEAFLET TETHERING AND RESTRICTION. THE TRANSEPTAL WAS CHALLENGING DUE TO A LARGE ATRIUM AND POSITION. THE TRANSEPTAL WAS ATTEMPTED TWICE TO ACHIEVE DESIRED POSITIONING. THE FIRST MITRACLIP (CDS0602-XTR, 10722R114) WAS IMPLANTED WITHOUT AN ISSUE REPORTED, HOWEVER, THE CLIP DETACHED FROM THE ANTERIOR LEAFLET, WHILE REMAINING ATTACHED TO THE POSTERIOR LEAFLET, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). CHORDAL INJURY OF THE ANTERIOR LEAFLET, WITH A NEW FLAIL, WAS NOTED DUE TO THE SLDA. AS TREATMENT, AN NTR MITRACLIP (CDS0602-NTR, 10607R10) WAS ATTEMPTED, HOWEVER, IT WAS DIFFICULT TO GRASP. THE DEVICE WAS REMOVED WITHOUT AN ISSUE REPORTED AND AN XTW WAS SUCCESSFULLY USED IN REPLACEMENT. THE SAME NTR THAT HAD BEEN REMOVED WAS ON THE STERILE TABLE AND ATTEMPTED FOR RE-USE. THE PHYSICIAN ATTEMPTED TO SLIDE THE CLIP INTRODUCER OVER THE CLIP, HOWEVER, THE TIP OF THE CLIP INTRODUCER BROKE. THE NTR DEVICE WAS SET ASIDE AND NOT USED ANYMORE. AS ADDITIONAL TREATMENT FOR THE SLDA, THE THIRD AND FOURTH MITRACLIPS WERE IMPLANTED WITHOUT A DEVICE ISSUE REPORTED, STABILIZING THE SLDA CLIP. THE MR REMAINED UNCHANGED AT GRADE 4+. DUE TO THE UNCHANGED MR, THE PATIENT REQUIRED ADDITIONAL HOSPITALIZATION DUE TO HEART FAILURE. REPORTEDLY, THERE WAS A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978283 MITRACLIP XTR CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR 10722R114

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R STEERABLE GUIDE CATHETER.