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

Model Number	EVOLUTPRO-23-US
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921); Device Dislodged or Dislocated (2923); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a transcatheter aortic valve implant procedure, the valve dislodged.Subsequently, a second valve was im planted.
Additional Manufacturer Narrative
Continuation of d10: product id envpro-16-us (lot: 0012976353); product type: 0195-heart valves; 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 during a transcatheter aortic valve implant procedure, the valve dislodged.Subsequently, a second valve was im planted.Additional information was received that a non-medtronic guidewire was used during the implant procedure and a pre-implant balloon aortic valvuloplasty (bav) was performed.The deployment starting point was at the mid-pigtail.Upon the first deployment attempt, the valve was found to be at a relatively high position and a recapture was attempted; however, the valve was unable to be recaptured.Therefore, the valve and delivery catheter system (dcs) were pulled to the descending aorta and deployed.It was clarified that the valve did not dislodge after release from the dcs.A post-implant bav was not performed after the implant of the first valve.A second transcatheter valve was implanted in the native aortic valve; however, restricted valve morphology and a mean pressure gradient of 40 millimeters of mercury (mm hg) were observed.Therefore, a post-implant bav was performed for the second valve while the patient was rapidly paced.After the post-implant bav, the valve's morphology improved.Per the physician, the patient's severe calcific ation and fusion contributed to the event.Additional information was received that the mean gradient before the second valve was implanted was 20 millimeters of mercury (mm hg).After the second valve was implanted, the implant depth on the non-coronary cusp (ncc) was 3 millimeters (mm), and the implant depth on the left coronary cusp (lcc) was 5 mm.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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: brand name: 20fr deliv sys envpro-16-us; product id: en vpro-16-us; serial/lot: (b)(6); udi: (b)(4); manufactured date: 2025-08-19; use by date: 2027-08-19; implant date: n/a; fda site id: 9612164.H6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.Additional codes.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, the valve dislodged.Subsequently, a second valve was im planted.Additional information was received that a non-medtronic guidewire was used during the implant procedure and a pre-implant balloon aortic valvuloplasty (bav) was performed.The deployment starting point was at the mid-pigtail.Upon the first deployment attempt, the valve was found to be at a relatively high position and a recapture was attempted; however, the valve was unable to be recaptured.Therefore, the valve and delivery catheter system (dcs) were pulled to the descending aorta and deployed.It was clarified that the valve did not dislodge after release from the dcs.A post-implant bav was not performed after the implant of the first valve.A second transcatheter valve was implanted in the native aortic valve; however, restricted valve morphology and a mean pressure gradient of 40 millimeters of mercury (mm hg) were observed.Therefore, a post-implant bav was performed for the second valve while the patient was rapidly paced.After the post-implant bav, the valve's morphology improved.Per the physician, the patient's severe calcifi cation and fusion contributed to the event.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC 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: 24507706
• Report Number: 9617601-2026-01585
• Device Sequence Number: 21454189
• Product Code: NPT
• UDI-Device Identifier: 00763000017811
• UDI-Public: (01)00763000017811(17)270627
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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: EVOLUTPRO-23-US
• Device Catalogue Number: EVOLUTPRO-23-US
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided; 03/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/10/2026; 03/12/2026
• Date Device Manufactured: 08/26/2025
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 55 KG