MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTFX-23
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
Date of Event	11/18/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient in the hospital with critical heart failure and ischemia underwent a procedure involving the implantation of an evolutfx-23 valve.The patient presented with low blood pressure, recorded at 80/45 mmhg at the start of the procedure.The valve was advanced to the annulus and deployed; however, the blood pressure dropped to 40/20 mmhg.The valve was deployed to 80% and pacing was stopped, but the blood pressure did not recover.Despite the use of anesthesia for sedation and administration of lifesaving medications, the patient's condition did not improve.The valve was recaptured and pulled back into the descending aorta, and cardiopulmonary resuscitation (cpr) was initiated.The valve was then implanted.Cpr and medications continued.The patient's rhythm changed to ventricular flutter.Subsequently, defibrillation was performed and cpr continued.A diagnostic coronary angiogram showed open coronaries.An echocardiogram revealed no perforation or regurgitation.The patient did not convert from ventricular flutter after multiple shocks and advanced cardiac life support, and the patient was pronounced deceased.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx dcs; product id d-evolutfx-2329 (unknown serial/lot); product type: 0195-heart valves.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.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx dcs; product id: d-evolutfx-2329; lot number: 0012230459; product type: 0195-heart valves; explant date: updated data: h6.H11.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.

• Brand Name: EVOLUT FX VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20798412
• Report Number: 2025587-2024-06888
• Device Sequence Number: 18094994
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: 00763000370688
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2026
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/16/2024
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Sex: Female