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

Model Number	VNMC3131C182TU
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
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 navion stent graft was implanted, during an unknown endovascular procedure.It was reported, approximately 6 years post, the index procedure.That the patient, rang technical services and stated, that the valiant navion stent graft was fractured.The patient stated, that they had bleeding issues, but that they don't know where it's coming from.The patient, also had shortness of breath and pressure in their back.The patient said, that the physician sent a letter stating, that the stent graft is broken and is under recall for possible fractures.The patient had a 6 month follow up with the physician, but no intervention was performed.The patient stated, that ultrasounds have been taken and that they cause pain.No cause was provided.No additional clinical sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
B5; additional information received: it was reported that the latest reviewed ct scan from approximately 4 years and 9 months post-index procedure showed no evidence of sent fractures.The physician did not reference any abnormality with stent graft position or structural integrity.It was confirmed that the patient has no history of acute or chronic bleeding as a result of the navion stent graft or any other prior intervention.Per the physician, there was no pressure or growth as a result of the navion stent graft.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 patient contacted technical services to voice concerns about health issues (blood clots in her legs, copd, emphysema, weight loss, throat issues, lack of energy, lower back pain and pressure in her back, venous collapse), patient is concerned of experiencing a cardiac arrest or cva.As previous assessed , the physician have confirmed no stent graft graft issues.Patient advised by technical services to follow up with the physician with her concerns.Core lab review of imaging from approximately 9 months and 57 months post index procedure did not observe any endoleak, fracture, stent ring enlargement, stent ring migration or aortic enlargement 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 confirmed that none of the symptoms that the patient is presenting with are congruent with the last cta.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 NAVION
• 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: 20084119
• Report Number: 9612164-2024-03899
• Device Sequence Number: 7736416
• Product Code: MIH
• UDI-Device Identifier: 00763000100988
• UDI-Public: 00763000100988
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 09/10/2020
• Device Model Number: VNMC3131C182TU
• Device Catalogue Number: VNMC3131C182TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 01/02/2025; 02/04/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/30/2024; 01/14/2025; 02/05/2025
• Date Device Manufactured: 09/11/2018
• 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
• Patient Age: 65 YR
• Patient Sex: Female