MAUDE Adverse Event Report: Medtronic Ireland EVOLUT FX DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVOLUTFX-2329
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty was performed due to calcification.During the first deployment attempt, inside the patient's native annulus, the valve dislodged and subsequently was recaptured.During the second deployment attempt, the valve was deployed at the target implant depth of 4 millimeter¿s (mm) on the non-coronary cusp (ncc) and 4 mm on the left coronary cusp (lcc).Prior to withdrawing the delivery catheter system (dcs), the nose cone was centered within the frame inflow by slightly retracting the medtronic guidewire.Following the implant of the valve, as the delivery catheter system (dcs) was withdrawn, the nose cone interacted with the outflow of the valve and subsequently the valve dislodged to the ascending aorta resulting in paravalvular leak (pvl).The dislodged valve was snared and a second system was used to cross the first valve.During the attempted implant of the second valve, an aortic dissection was observed during an aortic root shot.The patient was converted to open heart surgery, and the ascending aorta was repaired to address the dissection.The dislodged valve was explanted and a surgical valve was implanted.It was noted that a 1 hour procedural delay occurred while the dislodged valve was snared and the second valve deployment was attempted.
Additional Manufacturer Narrative
D10.Continuation - concomitant medical devices in use during the event include: medtronic product id: evfxplus-26; product serial/lot number: (b)(6); product type: 0195-heart valves; implant date: b)(6) 2026; explant date: b)(6) 2026 medtronic product id: d-evolutfx-2329; product serial/lot number: (b)(6); product type: 0195-heart valves; implant date: non-imp lantable; explant date: non-implantable medtronic product id: evfxplus-26; product serial/lot number: unknown; product type: 0195-heart valves; implant date: na; explant date: na medtronic product id: gwbc30; product serial/lot number: unknown; product type: 0195-heart valves; implant date: non-implantable; explant date: non-implantable 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 ; +353(091)708096
• MDR Report Key: 50564533
• Report Number: 9612164-2026-04395
• Device Sequence Number: 10521777
• Product Code: NPT
• UDI-Device Identifier: 00763000942700
• 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
• 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): 09/30/2026

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-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0013503162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 06/18/2026
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female