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	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Rupture (2208); Pericardial Effusion (3271)
Date of Event	04/07/2026
Type of Reportable Event	Death
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: unknown); product type: 0195-heart valves; 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.
Event or Problem Description
It was reported that during a transcatheter aortic valve implant procedure, a pre-implant balloon aortic valvuloplasty (bav) was com pleted due to calcification.The delivery catheter system (dcs) was then inserted into the patient and advanced to the native aortic annulus.The valve was then partially deployed in that it was positioned approximately 4 millimeters (mm) from the non-coronary cusp (ncc) and 4 mm from the left coronary cusp (lcc).Despite following training guidance for slow deployment of the valve and centering of the dcs nosecone by slightly retracting the guidewire, the nosecone suddenly moved during final deployment, causing dcs interaction with the valve.This interaction caused the valve to embolize into the patient's ascending aorta.Subsequently, the attending physician opted to attempt implantation of a second valve, so a new valve was prepared and loaded into the dcs.As the dcs was advanced towards the aortic annulus, the previously dislodged valve became unstable.Therefore, a snare was utilized to grasp the dislodged valve to maintain its position in relation to the great vessels as the second valve was successfully implanted.After implantation of the second valve, an echocardiogram was obtained which revealed a considerable pericardial effusion.In response, emergent surgical pericardiocentesis was performed with the implementation of an evacuation tube.The patient was then intubated, and cardiopulmonary resuscitation (cpr) was performed, but ultimately the patient died.Per the physician, the patient's death was due to pericardial effusion that was caused by "rupture" due to the dislodged valve.Per the physician, the dcs, valve, and procedure contributed to the patient's death.Per the physician, the patient's anatomy contributed to sudden change of dcs nosecone position when deploying the valve that led to valve dislodgement.
Additional Manufacturer Narrative
Updated data: b5.D.This is a system report.The section d.Information is for the primary device, which was in use with the following device(s) which cannot be excluded as potential contributing factors to the adverse event: medtronic brand name: deliv sys d-evolutfx-2329; product id: d-evolutfx-2329; lot: 0013259443; udi: (b)(4); manufactured date: 2026-01-27; use by date: 2028-01-27; implant date: n/a; fda site id: 9612164.H6.Annex a code, annex b codes.Corrected data: h6.Annex e code was erroneously omitted from the initial medwatch.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
It was reported that during a transcatheter aortic valve implant procedure, a pre-implant balloon aortic valvuloplasty (bav) was completed due to calcification.The delivery catheter system (dcs) was then inserted into the patient and advanced to the native aortic annulus.The valve was then partially deployed in that it was positioned approximately 4 millimeters (mm) from the non-coronary cusp (ncc) and 4 mm from the left coronary cusp (lcc).Despite following training guidance for slow deployment of the valve and centering of the dcs nosecone by slightly retracting the guidewire, the nosecone suddenly moved during final deployment, causing dcs interaction with the valve.This interaction caused the valve to embolize into the patient's ascending aorta.Subsequently, the attending physician opted to attempt implantation of a second valve, so a new valve was prepared and loaded into the dcs.As the dcs was advanced towards the aortic annulus, the previously dislodged valve became unstable.Therefore, a snare was utilized to grasp the dislodged valve to maintain its position in relation to the great vessels as the second valve was successfully implanted.After implantation of the second valve, an echocardiogram was obtained which revealed a considerable pericardial effusion.In response, emergent surgical pericardiocentesis was performed with the implementation of an evacuation tube.The patient was then intubated, and cardiopulmonary resuscitation (cpr) was performed, but ultimately the patient died.Per the physician, the patient's death was due to pericardial effusion that was caused by "rupture" due to the dislodged valve.Per the physician, the dcs, valve, and procedure contributed to the patient's death.Per the physician, the patient's anatomy contributed to sudden change of dcs nosecone position when deploying the valve that led to valve dislodgement.Additional information was received that the transfemoral approach was used as the access site.The cuspal overlap technique was not used as the physician does not use this technique.After reviewing the post-transcatheter aortic valve replacement (tavr) transesophageal echocardiogram (tee), the physician believes an annular rupture occurred.Per the physician, the second valve and second dcs did not cause or contribute to the death, and there were no complaints with the medtronic guidewire in relation to the death.

• 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: 24847844
• Report Number: 9617601-2026-02409
• Device Sequence Number: 8946645
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• UDI-Public: (01)00763000716134(17)271204(20)01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/04/2026

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-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: 04/07/2026
• Supplement Date Received by Manufacturer: 04/11/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/04/2026
• 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; Death
• Patient Sex: Female
• Patient Weight: 98 KG