BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 21606481 · Received March 14, 2025

    Report

    Report Number
    2135147-2025-01281
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    January 1, 2016
    Report Date
    March 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRICLIP WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, HYPERLIPIDEMIA, DIABETES, MYOCARDIAL INFARCTION, ISCHEMIC HEART DISEASE, CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION, CHRONIC KIDNEY DISEASE, STROKE/TIA, COPD, ASTHMA, LIVER DISEASE, ANEMIA, PERIPHERAL VASCULAR DISEASE, DEMENTIA, DEPRESSION, CANCER, ARTHRITIS, OBESITY, FUNCTIONAL TRICUSPID REGURGITATION, SECONDARY TRICUSPID REGURGITATION, RHEUMATIC DISEASE, PACEMAKER, PULMONARY HYPERTENSION, PRIOR CARDIAC SURGERY. COMPLICATIONS REPORTED INCLUDED HOSPITALIZATION, REINTERVENTION WITH T-TEER, RECURRENT TRICUSPID REGURGITATION, DEATH, ISCHEMIC STROKE, INTRACEREBRAL HEMORRHAGE, ACUTE KIDNEY INJURY, CARDIOGENIC SHOCK, PERMANENT PACEMAKER, RESPIRATORY COMPLICATIONS, POSTOPERATIVE HEMORRHAGE, TRANSFUSION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEART 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.

    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. ADDITIONAL PATIENT EFFECTS MENTIONED IN B5 WILL BE FILED UNDER A SEPARATE REPORT NUMBER. B3 EVENT DATE IS ESTIMATED. LITERATURE ATTACHMENT: COMPARISON OF TRANSCATHETER VERSUS SURGICAL TRICUSPID REPAIR AMONG PATIENTS WITH TRICUSPID REGURGITATION: TWO-YEAR RESULTS.

    Description of Event or Problem · 0

    THE ARTICLE "COMPARISON OF TRANSCATHETER VERSUS SURGICAL TRICUSPID REPAIR AMONG PATIENTS WITH TRICUSPID REGURGITATION: TWO-YEAR RESULTS" WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE MULTI CENTER STUDY, TO COMPARE OUTCOMES OF PATIENTS WITH TRICUSPID REGURGITATION (TR) TREATED WITH TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER) VERSUS SURGICAL TRICUSPID VALVE REPAIR. DEVICES MENTIONED INCLUDE TRICLIP, MITRACLIP, AND PASCAL. THE ARTICLE CONCLUDED THAT AMONG MEDICARE BENEFICIARIES, 2-YEAR MORTALITY AND HEART FAILURE HOSPITALIZATION RATES WERE COMPARABLE BETWEEN THE 2 GROUPS. NOTABLY, T-TEER SHOWED ADVANTAGES IN PERIOPERATIVE OUTCOMES, INCLUDING IN-HOSPITAL MORTALITY AND PACEMAKER IMPLANTATION RATES WHILE TRICUSPID VALVE REINTERVENTIONS WERE MORE FREQUENT IN THE T-TEER GROUP. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS TOSHIKI KUNO, AT N, MASSACHUSETTS GENERAL HOSPITAL AND HARVARD MEDICAL SCHOOL, BOSTON, USA WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS JULY 2016 TO DECEMBER 2020. A TOTAL OF 1143 (409 T-TEER) PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. FOR T-TEER GROUP, AVERAGE AGE WAS 81 AND MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, HYPERLIPIDEMIA, DIABETES, MYOCARDIAL INFARCTION, ISCHEMIC HEART DISEASE, CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION, CHRONIC KIDNEY DISEASE, STROKE/TIA, COPD, ASTHMA, LIVER DISEASE, ANEMIA, PERIPHERAL VASCULAR DISEASE, DEMENTIA, DEPRESSION, CANCER, ARTHRITIS, OBESITY, FUNCTIONAL TRICUSPID REGURGITATION, SECONDARY TRICUSPID REGURGITATION, RHEUMATIC DISEASE, PACEMAKER, PULMONARY HYPERTENSION, PRIOR CARDIAC SURGERY. PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED HOSPITALIZATION, REINTERVENTION WITH T-TEER, RECURRENT TRICUSPID REGURGITATION, DEATH, ISCHEMIC STROKE, INTRACEREBRAL HEMORRHAGE, ACUTE KIDNEY INJURY, CARDIOGENIC SHOCK, PERMANENT PACEMAKER, RESPIRATORY COMPLICATIONS, POSTOPERATIVE HEMORRHAGE, TRANSFUSION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEART FAILURE.

    Description of Event or Problem · 0

    THE ARTICLE "COMPARISON OF TRANSCATHETER VERSUS SURGICAL TRICUSPID REPAIR AMONG PATIENTS WITH TRICUSPID REGURGITATION: TWO-YEAR RESULTS" WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE MULTI CENTER STUDY, TO COMPARE OUTCOMES OF PATIENTS WITH TRICUSPID REGURGITATION (TR) TREATED WITH TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER) VERSUS SURGICAL TRICUSPID VALVE REPAIR. DEVICES MENTIONED INCLUDE TRICLIP, MITRACLIP, AND PASCAL. THE ARTICLE CONCLUDED THAT AMONG MEDICARE BENEFICIARIES, 2-YEAR MORTALITY AND HEART FAILURE HOSPITALIZATION RATES WERE COMPARABLE BETWEEN THE 2 GROUPS. NOTABLY, T-TEER SHOWED ADVANTAGES IN PERIOPERATIVE OUTCOMES, INCLUDING IN-HOSPITAL MORTALITY AND PACEMAKER IMPLANTATION RATES WHILE TRICUSPID VALVE REINTERVENTIONS WERE MORE FREQUENT IN THE T-TEER GROUP. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS TOSHIKI KUNO, AT N, MASSACHUSETTS GENERAL HOSPITAL AND HARVARD MEDICAL SCHOOL, BOSTON, USA WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS JULY 2016 TO DECEMBER 2020. A TOTAL OF 1143 (409 T-TEER) PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. FOR T-TEER GROUP, AVERAGE AGE WAS 81 AND MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, HYPERLIPIDEMIA, DIABETES, MYOCARDIAL INFARCTION, ISCHEMIC HEART DISEASE, CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION, CHRONIC KIDNEY DISEASE, STROKE/TIA, COPD, ASTHMA, LIVER DISEASE, ANEMIA, PERIPHERAL VASCULAR DISEASE, DEMENTIA, DEPRESSION, CANCER, ARTHRITIS, OBESITY, FUNCTIONAL TRICUSPID REGURGITATION, SECONDARY TRICUSPID REGURGITATION, RHEUMATIC DISEASE, PACEMAKER, PULMONARY HYPERTENSION, PRIOR CARDIAC SURGERY. PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED HOSPITALIZATION, REINTERVENTION WITH T-TEER, RECURRENT TRICUSPID REGURGITATION, DEATH, ISCHEMIC STROKE, INTRACEREBRAL HEMORRHAGE, ACUTE KIDNEY INJURY, CARDIOGENIC SHOCK, PERMANENT PACEMAKER, RESPIRATORY COMPLICATIONS, POSTOPERATIVE HEMORRHAGE, TRANSFUSION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112111 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| L| H| R| O