{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MENLO PARK", "manufacturer_contact_address_1": "5050 NATHAN LANE N", "manufacturer_contact_pcity": "65175654", "event_type": "Injury", "report_number": "2135147-2026-02447", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260415", "manufacturer_address_2": "", "pma_pmn_number": "P100009", "date_of_event": "20160101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55442", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6517565400", "noe_summarized": "1", "manufacturer_contact_l_name": "KROUSE", "source_type": [ "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94025", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "651", "date_added": "20260415", "manufacturer_contact_f_name": "KAREN", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "103510", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260415", "brand_name": "MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM", "generic_name": "VALVE REPAIR", "manufacturer_d_name": "ABBOTT MEDICAL", "manufacturer_d_address_1": "5050 NATHAN LANE N", "manufacturer_d_address_2": "", "manufacturer_d_city": "PLYMOUTH", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55442", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55442", "device_operator": "HEALTH PROFESSIONAL", "model_number": "UNK CDS", "catalog_number": "UNK CDS", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NKM", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Mitral Valve Repair Devices", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Off-Label Use" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260501", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6517", "patient": [ { "patient_sequence_number": "1", "date_received": "20260415", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Heart Failure/Congestive Heart Failure", "Tricuspid Valve Insufficiency/ Regurgitation" ] } ], "distributor_city": "", "date_report": "20260415", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "PLYMOUTH", "mdr_report_key": "24887023", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260323", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94025", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005070406", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "398471140", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP DELIVERY SYSTEM WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, ATRIAL FIBRILLATION, ATRIAL FLUTTER, HEART FAILURE, PERIPHERAL EDEMA, ASCITES, JUGULAR VEIN DISTENSION, AND PRIOR MYOCARDIAL INFARCTION, CORONARY DISEASE, STROKE, TRANSIENT ISCHEMIC ATTACK AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. COMPLICATIONS REPORTED INCLUDED OFF-LABEL USE, HEART FAILURE, TRICUSPID REGURGITATION, HOSPITALIZATION/PROLONGED-HOSPITALIZATION, DEATH; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. THE REPORTED IFU DEVIATION/OFF-LABEL USE WAS ASSOCIATED WITH DEVICE IMPLANT IN THE 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. LITERATURE ATTACHMENT: PREDICTING OUTCOMES IN PATIENTS WITH TRICUSPID REGURGITATION UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR USING AN ARTIFICIAL INTELLIGENCE¿DERIVED RISK SCORE. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED." }, { "mdr_text_key": "398471141", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE ARTICLE, \"PREDICTING OUTCOMES IN PATIENTS WITH TRICUSPID REGURGITATION UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR USING AN ARTIFICIAL INTELLIGENCE¿DERIVED RISK SCORE\", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE AND VALIDATE A ROBUST, RELIABLE RISK SCORE FOR PREDICTING MORTALITY AND CLINICAL OUTCOMES IN PATIENTS UNDERGOING TRICUSPID- TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER). THE DEVICES INCLUDED IN THE STUDY WERE PASCAL, MITRACLIP, AND TRICLIP. THE ARTICLE CONCLUDED THAT THE EUROTR SCORE OFFERS AN EASY-TO-USE, EXTERNALLY VALIDATED, ACCURATE RISK STRATIFICATION TOOL FOR PATIENTS UNDERGOING T-TEER. IT SUPPORTS PERSONALIZED TREATMENT STRATEGIES AND THE DESIGN OF FUTURE CLINICAL TRIALS; HELPING OPTIMIZE PATIENT SELECTION AND ENHANCE SHARED DECISION-MAKING WITHIN MULTIDISCIPLINARY HEART TEAMS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS JÖRG HAUSLEITER, MEDIZINISCHE KLINIK UND POLIKLINIK I, LMU KLINIKUM, LMU MÜNCHEN, MUNICH, GERMANY, WITH CORRESPONDING E-MAIL: JOERG.HAUSLEITER@MED.UNI-MUENCHEN.DE.]. THIS STUDY INCLUDED PATIENTS WITH SEVERE SYMPTOMATIC TRICUSPID REGURGITATION (TR) UNDERGOING T-TEER FROM 01 JANUARY 2016 TO 31 DECEMBER 2022. A TOTAL OF 1,826 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN NUMBER RECEIVED ABBOTT DEVICES. THE AVERAGE AGE WAS 80 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, ATRIAL FIBRILLATION, ATRIAL FLUTTER, HEART FAILURE, PERIPHERAL EDEMA, ASCITES, JUGULAR VEIN DISTENSION, AND PRIOR MYOCARDIAL INFARCTION, CORONARY DISEASE, STROKE, TRANSIENT ISCHEMIC ATTACK AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3885 BOHANNON DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55442", "manufacturer_contact_exchange": "651", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }