MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-26
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Activation Failure (3270); Patient Device Interaction Problem (4001); Unspecified Valve Regurgitation (4080)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/27/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a transcatheter aortic valve implant procedure, the delivery catheter system (dcs) was inserted into the patient and advanced to the aortic annulus.The valve was then deployed in that it was positioned 3-millimeters (mm) from the non-coronary cusp (ncc) and 3 mm from the left coronary cusp (lcc).After full deployment of the valve, it was identified that the valve had under expanded.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was completed as the patient was rapid paced.As the post-implant bav was completed, the valve dislodged in that it was positioned -2 mm from the ncc and -2 mm from the lcc.Due to the valve dislodgement, the patient experienced regurgitation of unknown severity.In response, the attending physician decided to implant a second transcatheter valve in the previously implanted valve.After implantation of the second valve, the patient was transferred to recovery.While in recovery, the patient decompensated so they were brought back to the catheterization lab.While in the catheterization lab, it was identified that the second valve had embolized.Subsequently, the patient experienced cardiac arrest and ultimately died.Per the physician, the patient's fibrosis contributed to the patient's death.
Additional Manufacturer Narrative
D10.Continuation - concomitant medical devices in use during the event include: medtronic product id: d-evolutfx-2329 ; product serial/lot number: (unknown); product type: (0195 - heart valves); implant date: not -implantable; explant date: na.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.
Event or Problem Description
Additional information was received that a non-medtronic guidewire was used for the procedure.Severe paravalvular leak was present after the first valve dislodged.The second valve was implanted at a depth of 3 mm on the ncc and 4 mm on the lcc.While the patient was in recovery, cardiac arrest occurred and cardiopulmonary resuscitation (cpr) was initiated.It was identified that the second valve dislodged following prolonged cpr.Additionally, it was noted that the patient had a low hemoglobin but did not accept blood products due to religious reasons.
Additional Manufacturer Narrative
Updated data: b5; 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.

• 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 ; 091708096
• MDR Report Key: 25323857
• Report Number: 9617601-2026-03471
• Device Sequence Number: 12085081
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)270909(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVFXPLUS-26
• Device Catalogue Number: EVFXPLUS-26
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/01/2026
• Date Device Manufactured: 09/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 73 KG