BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP NTR CLIP DELIVERY SYSTEM

    MDR report key: 16611874 · Received March 24, 2023

    Report

    Report Number
    2135147-2023-01338
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    February 27, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648226342
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AS IT COULD NOT BE DETERMINED WHICH OF THE TWO NTR CLIPS DETACHED AND RESULTED IN SLDA, A REVIEW OF THE LOT HISTORY RECORDS FOR BOTH THE NTR LOTS ASSOCIATED WAS PERFORMED AND IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY FOR BOTH THE LOTS IDENTIFIED NO SIMILAR COMPLAINTS FROM THE LOTS. ALL INFORMATION WAS INVESTIGATED AND BASED ON THE INFORMATION PROVIDED, A CAUSE FOR THE REPORTED SLDA COULD NOT BE DETERMINED. MITRAL VALVE INSUFFICIENCY/REGURGITATION (MR) RESULTING IN DYSPNEA (SHORTNESS OF BREATH) AND FATIGUE APPEARS TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS. DYSPNEA, FATIGUE AND MITRAL REGURGITATION ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    THE CLIP REMAINS IN THE 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH AND FATIGUE.

    Description of Event or Problem · 0

    THIS WILL BE FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND WORSENING MITRAL REGURGITATION. IT WAS REPORTED THAT ON (B)(6) 2019, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4. TWO MITRACLIP NTR WERE IMPLANTED WITHOUT ISSUE, REDUCING TO GRADE 1. ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED ONE OF THE IMPLANTED CLIPS HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO INCREASE TO A GRADE OF 4+. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376167 MITRACLIP NTR CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL CDS0601-NTR 08717648226342

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Hospitalization IMPLANTED MITRACLIP