MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-29
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Hemodynamic instability (4868)
Date of Event	08/26/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed with a non-medtronic 22 millimeter (mm).Upon the first deployment attempt, the valve was positioned too deep.Subsequently, the valve was recaptured into the delivery catheter system (dcs).Upon the second deployment attempt, the valve was positioned correctly at 80% deployment, however upon turning off the temporary pacing, it was observed that the patient had no blood pressure.The valve was fully deployed, however the patient's blood pressure did not return upon full release.Cardiopulmonary resuscitation (cpr) was initiated, and a transesophageal echocardiogram (tee) was performed revealing pericardial effusion.The dcs was removed, and pericardiocentesis was performed.Aortogram was performed, revealing acceptable coronary flow and no aortic root injury or annular rupture.The anatomical source of the effusion could not be confirmed, and the patient ultimately died later that day.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: d -evolutfx-2329, serial/lot #: (b)(6), ubd: 29-mar-2028, udi#: (b)(4) h6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.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 PLUS VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50759844
• Report Number: 9617601-2026-05613
• Device Sequence Number: 15840544
• Product Code: NPT
• UDI-Device Identifier: 00763000716141
• UDI-Public: (01)00763000716141(17)280311(20)01
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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 Model Number: EVFXPLUS-29
• Device Catalogue Number: EVFXPLUS-29
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 03/12/2026
• 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: Required Intervention; Hospitalization; Life Threatening; Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 295 LB