BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19587540 · Received June 21, 2024

    Report

    Report Number
    2135147-2024-02956
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    December 31, 2022
    Report Date
    July 11, 2024
    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 DEVICES WERE NOT RETURNED FOR ANALYSIS AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW. A REVIEW OF THE LOT HISTORY RECORD AND A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW, AND LOT/DEVICE INFORMATION IS NOT AVAILABLE. BASED ON AVAILABLE INFORMATION, THE REPORTED OFF-LABEL USE IS RELATED TO THE DEVICE BEING USED ON THE TRICUSPID VALVE. CAUSES FOR THE REPORTED DEATH, HEART FAILURE, AND TRICUSPID REGURGITATION COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DEATH AND HEART FAILURE AS LISTED IN THE MITRACLIP INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATIONS WERE THE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ATTACHMENT: ARTICLE TITLED ¿RESIDUAL TRICUSPID REGURGITATION AFTER TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR: INSIGHTS INTO THE EUROTR REGISTRY." A2: MEAN AGE. A3: MAJORITY GENDER. B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. D6A: DATE OF IMPLANT WAS ESTIMATED. H6: - ADVERSE EVENT PROBLEM: MEDICAL DEVICE PROBLEM CODE: 1494 OFF-LABEL USE WAS CODED FOR INDICATION FOR USE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ARTICLE TITLED ¿ RESIDUAL TRICUSPID REGURGITATION AFTER TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR: INSIGHTS INTO THE EUROTR REGISTRY" A2: MEAN AGE. A3: MAJORITY GENDER. B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. D6A: DATE OF IMPLANT WAS ESTIMATED. H6: - ADVERSE EVENT PROBLEM: MEDICAL DEVICE PROBLEM CODE: 1494 OFF-LABEL USE WAS CODED FOR INDICATION FOR USE.

    Description of Event or Problem · 0

    THE ARTICLE "RESIDUAL TRICUSPID REGURGITATION AFTER TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR: INSIGHTS INTO THE EUROTR REGISTRY" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI-CENTER STUDY ON THE PROGNOSTIC IMPACT OF RESIDUAL TRICUSPID REGURGITATION (TR) AFTER TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER). THE AIM OF THIS ANALYSIS WAS TO EVALUATE 2-YEAR SURVIVAL AND SYMPTOMATIC OUTCOMES OF PATIENTS IN RELATION TO RESIDUAL TR AFTER T-TEER, USING THE EUROPEAN REGISTRY OF TRANSCATHETER REPAIR FOR TRICUSPID REGURGITATION (EUROTR REGISTRY). DEVICES MENTIONED INCLUDE THE MITRACLIP AND TRICLIP. THE ARTICLE CONCLUDED THAT T-TEER EFFECTIVELY REDUCED TR SEVERITY IN THE MAJORITY OF PATIENTS. WHILE RESIDUAL TR GREATER OR EQUAL TO 3+ WAS ASSOCIATED WITH WORSE OUTCOMES, NO DIFFERENCES WERE OBSERVED FOR RESIDUAL TR 1+ VERSUS 2+. SYMPTOMATIC IMPROVEMENT CORRELATED WITH THE DEGREE OF TR REDUCTION. THE PRIMARY AUTHOR IS LUKAS STOLZ, MEDIZINISCHE KLINIK UND POLIKLINIK I, LMU KLINIKUM, LMU MÜNCHEN, MUNICH, GERMANY. THE CORRESPONDING AUTHOR IS: JÖRG HAUSLEITER, MARCHIONINISTR. (B)(6). THE TIME FRAME OF T HE STUDY WAS TAKEN FROM THE EUROTR REGISTRY, INCLUDING PATIENTS WHO UNDERWENT T-TEER FOR SYMPTOMATIC TR FROM 2016 TO 2022. A TOTAL OF 1286 PATIENTS WERE INCLUDED IN THIS STUDY, MAJORITY OF WHICH RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE OF THE PATIENTS ENROLLED WAS 78. THE MAJORITY GENDER WAS FEMALE. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDED: DEGENERATIVE TRICUSPID REGURGITATION, FUNCTIONAL TRICUSPID REGURGITATION, MIXED TRICUSPID REGURGITATION, ARTERIAL HYPERTENSION, DYSLIPIDEMIA, PERIPHERAL OEDEMA, ASCITES, JUGULAR VEIN DISTENSION, PRIOR MYOCARDIAL INFARCTION (MI), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), DIABETES MELLITUS, PRIOR STROKE, TV LEAD, AND CORONARY ARTERY DISEASE. COMPLICATIONS INCLUDED ALL-CAUSE MORTALITY, TRICUSPID REGURGITATION, SEVERE HEART FAILURE SYMPTOMS, AND HEART FAILURE HOSPITALIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156828 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization