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-29-US
Medical Device Problem Codes	Material Invagination (1336); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10:  product id envpro-16-us (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 first valve failed to unfold properly and did not meet the implantation requirements.Subsequently, the valve was recaptured and withdrawn from the patient.A new valve was then prepared and the delivery catheter system (dcs) was inserted into the patient.While attempting to implant the second valve, pericardial effusion was noted.In response, the valve and dcs were withdrawn from the patient.The patient was then provided surgical treatment for the pericardial effusion.
Additional Manufacturer Narrative
Updated data: b5.H6.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 first valve failed to unfold properly and did not meet the implantation requirements.Subsequently, the valve was recaptured and withdrawn from the patient.A new valve was then prepared and the delivery catheter system (dcs) was inserted into the patient.While attempting to implant the second valve, pericardial effusion was noted.In response, the valve and dcs were withdrawn from the patient.The patient was then provided surgical treatment for the pericardial effusion.Additional information was received to clarify that the first valve unfolding was an infold that occurred after partial recapture with high positioning.The same dcs was used for the attempted implant of the first and second valves.The pericardial effusion occurred during the attempted implant of the second valve.Per the physician, the non-medtronic guidewire contributed to the pericardial effusion; however, the valve and dcs did not cause or contribute to the pericardial effusion.
Additional Manufacturer Narrative
Updated data: b5.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 first valve failed to unfold properly and did not meet the implantation requirements.Subsequently, the valve was recaptured and withdrawn from the patient.A new valve was then prepared and the delivery catheter system (dcs) was inserted into the patient.While attempting to implant the second valve, pericardial effusion was noted.In response, the valve and dcs were withdrawn from the patient.The patient was then provided surgical treatment for the pericardial effusion.Additional information was received to clarify that the first valve unfolding was an infold that occurred after partial recapture with high positioning.The same dcs was used for the attempted implant of the first and second valves.The pericardial effusion occurred during the attempted implant of the second valve.Per the physician, the non-medtronic guidewire contributed to the pericardial effusion; however, the valve and dcs did not cause or contribute to the pericardial effusion.Additional information was received that there was no misload identified during loading of the first valve.The first valve was recaptured two times due to high positioning.A procedural delay occurred as a result of the infold.The second valve was never implanted in the patient, and the procedure was aborted due to the surgical treatment.Per the physician, the patient's severe calcification of the bicuspid aortic valve contributed to the infold.

• 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: 24831562
• Report Number: 9617601-2026-02366
• Device Sequence Number: 13053624
• Product Code: NPT
• UDI-Device Identifier: 00763000017835
• UDI-Public: (01)00763000017835(17)270620
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-29-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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 04/21/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/16/2026; 04/22/2026
• Date Device Manufactured: 08/19/2025
• 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...
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 75 KG