MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Catalog Number	VAMF3434C200TU
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A valiant captivia (vamf3434c200tu) was used along with a sentrant sheath (sensh2428w) on to a treat a loss of seal and migration of a non-medtronic stent graft implanted 10 days prior.The valiant captivia was inspected prior to use and a gap was noted between the tip and the graft cover.The physician still proceeded to use it.The device was prepared per the instructions for use and the hydrophilic coating was activated with saline.During the procedure, the sentrant sheath was inserted without issue.It was reported that when attempting to insert the valiant captivia stent graft delivery system into the sentrant sheath, significant resistance was encountered.The delivery system was pulled back and the gap was still observed.This irregularity could not be corrected despite manipulation of the delivery system.The physician was able to get the device in and deploy the stent graft without issue.There was resistance again when pulling the device out.Per the physician, the cause of the event was due to the observed gap.Additionally, it was noted that the tip of the valiant captivia delivery system graft did not appear smooth.The physician hypothesized that the issue was isolated to the graft.The sheath functioned as expected and the introducer was inserted without difficulty.The procedure was completed as planned.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Photo evaluation summary: two still images were received for analysis.Images depict the distal section of a valiant delivery system.A gap is evident between the graft cover and tip.Deformation is evident to the distal end of the tip.It was not possible to confirm the reported insertion or removal difficulties from the images provided.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: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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 ; 091708096
• MDR Report Key: 22517257
• Report Number: 9612164-2025-03463
• Device Sequence Number: 7951298
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: (01)00643169347366(17)250918
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 07/16/2025

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 Expiration Date: 09/18/2025
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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
• Patient Sex: Unknown