BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 16351804 · Received February 10, 2023

    Report

    Report Number
    2135147-2023-00461
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    April 1, 2019
    Report Date
    February 10, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 HEMORRHAGE, CEREBROVASCULAR ACCIDENT, AND MRS. HEMORRHAGE, CEREBROVASCULAR ACCIDENT, AND MR ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND SURGICAL INTERVENTION WERE RESULTS OF CASE SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE ADDITIONAL PATIENT EFFECT OF DEATH REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. MEAN AGE. MAJORITY GENDER. DATE OF EVENT WAS ESTIMATED AS (B)(6) 2019. THE TENDYNE DEVICE IS NOT MARKETED IN THE U.S. OR SIMILAR TO A DEVICE MARKETED IN THE U.S. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT WAS ESTIMATED AS (B)(6) 2019.

    Description of Event or Problem · 0

    THIS ARTICLE IS A RETROSPECTIVE SINGLE STUDY EXPERIENCE TO ASSESS THE CHARACTERISTICS AND OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) WITH THE TENDYNE SYSTEM IN COMPARISON WITH THOSE UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) WITH A MITRACLIP. TENDYNE MITRAL VALVE SYSTEM (ABBOTT MEDICAL), MITRACLIP SYSTEM (ABBOTT STRUCTURAL HEART), OR A NON-ABBOTT TEER DEVICE WERE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED THAT THE TENDYNE SYSTEM LED TO SUBSTANTIAL REDUCTION OF MITRAL REGURGITATION (MR) AND LEFT VENTRICLE (LV) REVERSE REMODELING THAN TEER. IN CONTRAST, THE 30-DAY MORTALITY RATE WAS HIGHER AFTER TMVR WITH THE TENDYNE COMPARED TO TEER. [THE PRIMARY AND CORRESPONDENCE AUTHOR OF THIS ARTICLE IS TETSU TENAKA, MD,DEPARTMENT OF INTERNAL MEDICINE, HEART CENTER BONN, UNIVERSITY HOSPITAL BONN, VENUSBERG-CAMPUS 1, 53127 BONN, GERMANY, WITH EMAIL ADDRESS : [email protected]] PERIOPERATIVE AND POST OPERATIVE COMPLICATIONS FOR TEER: UNCHANGED MR, STROKE, MAJOR LIFE-THREATENING BLEEDING, AND 4 DEATHS (3 OF THEM DUE TO CARDIOVASCULAR CAUSES). ADDITIONALLY, 8 OUT OF THE 17 PATIENTS TREATED WITH TENDYNE HAD A PRIOR HISTORY OF FAILED TEER PROCEDURES. A TOTAL OF 67 PATIENT WERE ELIGIBLE FOR THE STUDY AND ONLY 17 PATIENTS UNDERWENT TENDYNE MITRAL VALVE REPLACEMENT AND 46 WERE TREATED BY TEER (MITRACLIP OR A NON-ABBOTT TEER DEVICE) FROM APRIL 2019 TO OCTOBER 2021. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, "CHARACTERISTICS AND OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER MITRAL VALVE REPLACEMENT WITH THE TENDYNE SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066258 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R