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

Model Number	VAMF3430C150TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 index procedure to treat a dissection, the stent graft vamf3430c150tu valcap taper was difficult to deploy during nose cone extension, with torque build-up and stiffness noted in the deployment system when deploying the freeflo stents.It was confirmed that the deployment steps were followed per the instructions for use.The surgeon stated that the tip capture release handle was ¿sticky¿/tough to rotate.Resistance was felt during the deployment process.After torquing on the handle/dial it eventually ¿popped¿ open during deployment.It did not deploy slowly and not easily as it would likely do so if the graft was straight, or straighter that it was in this case.The covered stents deployed normally without issue.The physician noted that it felt like a mechanical problem with the release mechanism or perhaps some of the struts were overlapping each other in the bare metal section and were therefore wedged into the nose cone.There was some extra manipulation required in order to release the nose cone.Imaging conducted after deployment showed no issues with placement.It is not believed the patient's anatomy contributed to the deployment difficulty, as it was stated the aortic arch angulation was relatively normal.One day after the index procedure, the patient developed a type a aortic dissection and was promptly taken to the operating room, where the ascending aorta was replaced.No additional sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
B5; additional information received: per the physician, the cause of the dissection cannot be determined.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
Product analysis the stent graft had been deployed prior to receipt of the device and was not received alongside.Deformation was evident to the proximal graft cover.A kink was evident to the distal graft cover and tip capture peek tubing.The tip capture mechanism could be retracted with resistance noted.An in-house 0.035¿ guidewire was loaded to straighten the kinked section; the tip capture mechanism could then be advanced and retracted with no resistance noted.No other deformation evident to the remainder of the device.Additional information received: it was confirmed per the sales representative that attended the procedure that the guidewire was ma intained in the delivery system throughout the case and was not removed.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
Update to coding; 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.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 22433943
• Report Number: 9612164-2025-03330
• Device Sequence Number: 16932027
• Product Code: MIH
• UDI-Device Identifier: 00643169400146
• UDI-Public: (01)00643169400146(17)260917
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 09/17/2026
• Device Model Number: VAMF3430C150TU
• Device Catalogue Number: VAMF3430C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 10/03/2025; 10/15/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/09/2025; 10/15/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown