MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
Report
- Report Number
- 2135147-2025-01278
- Event Type
- Injury
- Date Received
- March 14, 2025
- Date of Event
- January 1, 2016
- Report Date
- March 25, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NKM
- PMA / PMN Number
- P100009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP 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 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, OFF-LABEL USE; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. THE REPORTED OFF-LABEL USE WAS ASSOCIATED WITH USING A MITRACLIP ON A TRICUSPID VALVE. 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. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.
IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS DETAILED IN B5 WILL BE FILED UNDER A SEPARATE REPORT. B2 DEATH DATE IS ESTIMATED. B3 EVENT DATE IS ESTIMATED. LITERATURE ATTACHMENT: COMPARISON OF TRANSCATHETER VERSUS SURGICAL TRICUSPID REPAIR AMONG PATIENTS WITH TRICUSPID REGURGITATION: TWO-YEAR RESULTS.
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.
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 |
|---|---|---|---|---|---|---|---|
| 1229073 | MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM | VALVE REPAIR | NKM | ABBOTT MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |