{ "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. 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MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "396709928", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, LEAFLET THICKENING WAS IDENTIFIED VIA COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) THAT WAS FURTHER ANALYZED VIA A NON-MEDTRONIC ARTIFICIAL INTELLIGENCE (AI)-POWERED SIMULATION. THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE PROCEDURE." }, { "mdr_text_key": "401568001", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED DATA: B2, B5, ADDITIONAL CODES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "401568002", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT 7 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, LEAFLET THICKENING WAS IDENTIFIED VIA COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) THAT WAS FURTHER ANALYZED VIA A NON-MEDTRONIC (DASI SOLUTIONS) ARTIFICIAL INTELLIGENCE (AI)-POWERED SIMULATION. THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED AS TREATMENT WITH A NON-MEDTRONIC TRANSCATHETER VALVE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "AV. PASEO DEL CUCAPAH #10510", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "04/21/2026;05/13/2026" } ] }