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

Model Number	EVFXPLUS-34
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the attempted implant of a transcatheter aortic valve, upon the first deployment attempt at a target implant depth of 2 millimeters (mm) on the native annulus, an infold was identified.Subsequently, the valve was recaptured, and the system was withdrawn from the patient.It was noted that \"echmo\" was provided as a treatment.Subsequently, a new valve and delivery catheter system (dcs) were opened and prepared.Following insertion into the patient, it was observed that the correct positioning of the valve could not be achieved.4 deployment attempts were made, however correct positioning was not achieved on any of the 4 attempts.Subsequently, the valve was recaptured for a final time, and the system was withdrawn from the patient.Per the physician, the patient's native bicuspid valve contributed to the infold.
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} 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
Updated data: b5.A second paragraph was added.E.Initial reporter name corrected data - inadvertently omitted from the initial medwatch 3500a: b2.Outcome attributed to adverse event d10.Concomitant device: product id: d-evolutfx-34, lot #: 0013259693 erroneously incorrect on the initial medwatch 3500a.Additional codes.Annex f code f1203 replaced f12.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 the attempted implant of a transcatheter aortic valve, upon the first deployment attempt at a target implant depth of 2 millimeters (mm) on the native annulus, an infold was identified.Subsequently, the valve was recaptured, and the system was withdrawn from the patient.It was noted that \"echmo\" was provided as a treatment.Subsequently, a new valve and delivery catheter system (dcs) were opened and prepared.Following insertion into the patient, it was observed that the correct positioning of the valve could not be achieved.Four deployment attempts were made; however, correct positioning was not achieved on any of the 4 attempts.Subsequently, the valve was recaptured for a final time and the system was withdrawn from the patient.Per the physician, the patient's native bicuspid valve contributed to the infold.Additional information was received to report the reference to \"echmo\" treatment was a spelling error and meant to indicate extracorporeal membrane oxygenation (ecmo).

• 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: 25150937
• Report Number: 9617601-2026-03070
• Device Sequence Number: 10730287
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• UDI-Public: (01)00763000716158(17)271112(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/24/2026

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-34
• Device Catalogue Number: EVFXPLUS-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: 05/11/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 11/12/2025
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 203 LB