BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 15472273 · Received September 23, 2022

    Report

    Report Number
    2135147-2022-01323
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    November 1, 2018
    Report Date
    September 22, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED HEART FAILURE. HEART FAILURE ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. DATES ESTIMATED. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE ADDITIONAL DEATH REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. ATTACHMENT: ARTICLE TITLED "UNVEILING CARDIAC AMYLOIDOSIS ITS CHARACTERISTICS, AND OUTCOMES AMONG PATIENTS WITH MR UNDERGOING TRANSCATHETER EDGE-TO-EDGE MV REPAIR".

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT HEART FAILURE AND HOSPITALIZATION. THIS PROSPECTIVE RESEARCH ARTICLE EVALUATED THE PREVALENCE, PREDICTORS, AND OUTCOMES OF CARDIAC AMYLOIDOSIS IN CONSECUTIVE PATIENTS REFERRED FOR TRANSCATHETER EDGE-TO-EDGE (TEER) THERAPY. IT WAS REPORTED THAT 120 PATIENTS UNDERWENT TEER USING A MITRACLIP OR PASCAL DEVICE BETWEEN NOVEMBER 2018 TO JANUARY 2021. COMPLICATIONS INCLUDED CARDIOVASCULAR DEATH, ALL CAUSE DEATH AND HYPERTENSIVE HEART FAILURE (HHF) REQUIRING HOSPITALIZATION. IN CONCLUSION, DUAL PATHOLOGY OF MITRAL REGURGITATION (MR) AND CARDIAC AMYLOIDOSIS IS COMMON IN ELDERLY PATIENTS WITH MR UNDERGOING TEER AND HAS WORSE POSTINTERVENTIONAL OUTCOMES COMPARED WITH LONE MR. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, "UNVEILING CARDIAC AMYLOIDOSIS ITS CHARACTERISTICS, AND OUTCOMES AMONG PATIENTS WITH MR UNDERGOING TRANSCATHETER EDGE-TO-EDGE MV REPAIR". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715353 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization