BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 21723701 · Received March 28, 2025

    Report

    Report Number
    2135147-2025-01644
    Event Type
    Death
    Date Received
    March 28, 2025
    Date of Event
    January 1, 2017
    Report Date
    April 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION ATTACHMENT: ARTICLE TITLED "OUTCOMES OF OCTOGENARIANS UNDERGOING EDGE-TO-EDGE TRANSCATHETER VALVE REPAIR FOR TRICUSPID REGURGITATION: INVERSE PROPENSITY SCORE-WEIGHTED ANALYSIS."

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING DIABETES, CHRONIC RENAL FAILURE, STROKE, PREVIOUS CARDIAC SURGERY, CONCOMITANT MITRACLIP, ATRIAL FIBRILLATION, PACEMAKER LEAD, COPD. COMPLICATIONS REPORTED INCLUDED DEATH, HOSPITALIZATION, MEDICATION REQUIRED, SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION, BLOOD TRANSFUSION, RENAL FAILURE; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. CODES REMOVED: HEALTH EFFECT-CLINICAL CODE: 2041 RENAL FAILURE. CODES ADDED: HEALTH EFFECT-CLINICAL CODE: 4580 INSUFFICIENT INFORMATION. B2: AS THIS IS FROM A LITERATURE REVIEW, THE EVENT DATE IS ESTIMATED. B3: AS THIS IS FROM A LITERATURE REVIEW, THE DEATH DATE IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ATTACHMENT: ARTICLE TITLED "OUTCOMES OF OCTOGENARIANS UNDERGOING EDGE-TO-EDGE TRANSCATHETER VALVE REPAIR FOR TRICUSPID REGURGITATION: INVERSE PROPENSITY SCORE-WEIGHTED ANALYSIS"

    Description of Event or Problem · 0

    THE ARTICLE "OUTCOMES OF OCTOGENARIANS UNDERGOING EDGE-TO-EDGE TRANSCATHETER VALVE REPAIR FOR TRICUSPID REGURGITATION: INVERSE PROPENSITY SCORE-WEIGHTED ANALYSIS" WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE SINGLE CENTER STUDY, TO EVALUATE THE CHARACTERISTICS AND OUTCOMES OF TEER IN OCTOGENARIANS. COMPARED TO THOSE IN PATIENTS UNDER 80 YEARS OLD TREATED AT A REFERRAL TERTIARY TEACHING HOSPITAL. DEVICES MENTIONED INCLUDE TRICLIP AND MITRACLIP. THE ARTICLE CONCLUDED THAT *CONCLUSION*. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS FABRIZIO MONACO AT IRCCS SAN RAFFAELE SCIENTIFIC INSTITUTE, VIA OLGETTINA 60, 20132 MILAN, ITALY, WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS JANUARY 2017 TO SEPTEMBER 2023. A TOTAL OF 101 PATIENTS (36 GREATER THAN OR EQUAL TO 80 YEARS OLD, LESS THAN 80 YEARS OLD) WERE INCLUDED IN THIS STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED DIABETES, CHRONIC RENAL FAILURE, STROKE, PREVIOUS CARDIAC SURGERY, CONCOMITANT MITRACLIP, ATRIAL FIBRILLATION, PACEMAKER LEAD, COPD. PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HOSPITALIZATION, MEDICATION REQUIRED, SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION, BLOOD TRANSFUSION, RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578811 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H| R