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

Model Number	EVOLUTFX-34
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id {d-evolutfx-2329}; product lot/serial number {(b)(6)}; product type: {0195-heartvalves}; implant date {non-implantable}.Select patient information cannot be included in the regulatory report due to regional privacy regulations.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 following the successful implant of a transcatheter aortic valve, the valve dislodged into the ascending aorta.Subsequently, a new valve was successfully implanted at a depth of 3 millimeters (mm).
Additional Manufacturer Narrative
Image review: a pre-implant patient executive summary was not provided, which limited the ability to conduct a comprehensive preprocedural anatomical assessment.Four intraprocedural fluoroscopic images were submitted for review in relation to the reported event.Fluoroscopic valve load inspection images were not provided; therefore, confirmation of appropriate valve loading could not be performed.Procedural documentation indicates that the valve dislodged to the ascending aorta sometime after the valve implantation.The dislodgement event was not captured in the submitted media; therefore, the cause of the valve dislodgement cannot be determined.Subsequently, a second valve was implanted.Based on the limited information and images provided, a comprehensive analysis could not be performed.Therefore, this review is inconclusive.Updated 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.
Event or Problem Description
It was reported that following the successful implant of a transcatheter aortic valve, the valve dislodged into the ascending aorta.Subsequently, a new valve was successfully implanted at a depth of 3 millimeters (mm).Additional information was received that a medtronic guidewire was initially used and was changed to a non-medtronic guidewire due to the s-shape anatomy between the aorticarch and descending aorta.A pre-implant balloon aortic valvuloplasty (bav) was not performed due to the physicians decision.The deployment starting point was at the bottom of the pigtail catheter.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) and left coronary cusp (lcc) was 3 mm.After valve dislodgement, the implant depth on the ncc and lcc was approximately -13 mm.It was reported that the valve dislodged down into the left ventricular and was interrupting the mitral valve function.Snaring was ongoing, and due to that, the valve dislodged to the ascending aorta above the sinotubular junction (stj).A post-implant bav was note performed prior to valve dislodgement.The patient's medical history of coronary artery bypass graft (cabg) and aortic repair were noted as contributing factors to the dislodge.
Additional Manufacturer Narrative
Updated data: b5.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 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: 24818201
• Report Number: 9617601-2026-02338
• Device Sequence Number: 13160475
• Product Code: NPT
• UDI-Device Identifier: 00763000370718
• UDI-Public: (01)00763000370718(17)260510
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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 Expiration Date: 05/10/2026
• Device Model Number: EVOLUTFX-34
• Device Catalogue Number: EVOLUTFX-34
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 04/20/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/09/2026; 04/27/2026
• Date Device Manufactured: 05/10/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male