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

Model Number	VAMC4040C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	11/20/2024
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
A valiant captivia stent graft was implanted during an endovascular procedure.It was reported that 2 weeks later intervention was performed where arch vessel revascularization due to ascending aortic aneurysm.Graft extension was carried out using non-medtronic devices the patient was hospitalised a month later.The patient had leukocytosis and a ct suggested potential endoleaks at modular attachment sites.No intervention was performed due to previous rapid degeneration.Infection is not suspected regarding the device or procedure.Patient did have pneumonia which does not seem related.Patient status is ¿not recovered/not resolved¿.The site, sponsor and investigator assessed the event as possibly related to the index procedure and not related to the device.
Additional Manufacturer Narrative
It was reported that the vascular surgery team decided to hold off on intervening at this time due to previous rapid degeneration.It was stated that the endoleak at the junction of the ascending aorta and arch may be type iii although a type ii endoleak from intercostal arteries may be more likely especially given reactive site stability of the thoracic aortic excluded aneurysmal sac.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
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
Additional information received: a type ic endoleak was identified approximately 1 year after the index procedure.A intervention was performed the following day.The event is noted as "recovering/resolving".The site assessed the type ic endoleak as probably related to the index procedure and not related to the study device.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
Additional information received: the site assessed the type ic endoleak as possibly related to the index procedure.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
Additional information received: it was reported that type iii endoleaks identified o6 weeks post implant were described as "type iii endoleaks at the modular attachment site," further characterized as a "type iiia, junctional leak or disconnect" type.The type ic endoleak into the false lumen was observed following a right carotid-subclavian bypass, not due to a medtronic device.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
Additional information received: it was reported that the type ic endoleak could have been caused by anatomical changes.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
Correction: it was reported previous that the type ic was observed post the bypass - the site have updated that the type ic endoleak into the false lumen was treated with a right carotid-subclavian bypass, not due to a medtronic device but could be caused by anatomical changes.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 - CW
• 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: 22317864
• Report Number: 9612164-2025-03113
• Device Sequence Number: 12998864
• Product Code: MIH
• UDI-Device Identifier: 00643169346833
• UDI-Public: (01)00643169346833(17)260819(21)V31486224
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/26/2026

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 Expiration Date: 08/19/2026
• Device Model Number: VAMC4040C150TU
• Device Catalogue Number: VAMC4040C150TU
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 07/11/2025; 10/29/2025; 01/13/2026; 02/10/2026; 02/11/2026; 02/11/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/29/2025; 11/21/2025; 02/06/2026; 02/11/2026; 02/12/2026; 02/26/2026
• Date Device Manufactured: 08/19/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American