MAUDE Adverse Event Report: MEDTRONIC IRELAND EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-34
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the implant of a transcatheter valve, the patient had a low ejection fraction (ef) of 30%, occluded left main artery, and multiple previously implanted stent grafts.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 25 millimeter (mm) non-medtronic balloon.The deployment of the valve was attempted two times while the patient was rapidly paced, and recaptured following each attempt due to a deep implant depth on the left coronary cusp (lcc).Following the second recapture, the patient became hypotensive.Subsequently, cardiopulmonary resuscitation (cpr) was performed, and advanced cardiovascular life support (acls) medication was administered.Ventricular fibrillation occurred and defibrillation was required.The physician decided to implant the transcatheter valve, and the patient was placed on extracorporeal membrane oxygenation (ecmo) following implantation.A transesophageal echocardiogram (tee) was performed that showed the valve was in good position, a single digit mean gradient, and no aortic insufficiency; however, a low ef of approximately 10% was noted.Additionally, there was no evidence of annular rupture or aortic dissection.Following the implant procedure, the patient was transferred to the intensive care unit (icu) on ecmo and intubation.Per the physician, the pacing runs during deployment contributed to the hypotension as the patient was not able to tolerate the rapid pacing.
Additional Manufacturer Narrative
Updated: d4, h4, h6.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 plus valve; product id evfxplus-34 (serial: (b)(6); product type: 0195-heart valves; implant date (b)(6) 2025; explant date n/a 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 DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23732605
• Report Number: 9612164-2025-06038
• Device Sequence Number: 13410351
• Product Code: NPT
• UDI-Device Identifier: 00763000942717
• UDI-Public: (01)00763000942717(17)270606(10)0012857311(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/13/2026

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: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012857311
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 06/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male