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

Model Number	VNMF3737C174TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Ulcer (2274); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B5; additional information received; it was noted the findings from the cta taken approx.1.5 months post the index procedure ((b)(6) 2020), represent the first post-operative ct scan following the urgent tevar performed on this patient for a type b dissection.The type ib endoleak was expected.The distal valiant navion stent graft ((b)(6)) was placed into dissected aorta.Due to the acute dissection, the physician avoided aggressive balloon dilation after stent deployment.There was no calcification or significant tortuosity.The intervention was performed to prevent retrograde filling into the aneurysm sac.On ((b)(6) 2020) approx.2 months post index procedure, it was noted that the physician requested a follow-up ct scan in three months considering a distal extension with a balloon if the issue persisted.However, the proximal aneurysm sac showed thrombosis.A repeat cta taken approx.34 months, post index procedure ((b)(6) 2023), revealed a type a imh of the ascending aorta.The patient was taken to the or 5 days later ((b)(6) 2023).One of the uncovered proximal barbs of the proximal valiant navion stent graft ((b)(6)) had caused an ulceration and the imh.With the arch open, the barb was cut with heavy wire cutters and the aorta was re paired internally, followed by a hemiarch replacement.The distal endoleak in question resolved, and the aneurysm sac in the descending aorta regressed.The bare stent eroded into the ascending aorta and caused the imh.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
Valiant navion stent grafts were implanted during endovascular treatment of a thoracic aortic dissection.Valiant stent graft (vnmf3737c174tu) was implanted in zones 1 and 2, while (vnmc3731c207tu) was implanted in zones 4 and 5.No device deficiencies were observed.It was reported 46 days post index procedure, that follow up ct scan with and without contrast revealed a type ib endoleak.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
This is a system report.The section d information is for the primary device, which was in use with the following: brand name valiant navion; product id vnmc3731c207tu (serial: (b)(6) ); product type: 0180-aortic stent graft; implant date (b)(6) 2020; explant date 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: 19750057
• Report Number: 9612164-2024-03254
• Device Sequence Number: 6532835
• Product Code: MIH
• UDI-Device Identifier: 00763000100681
• UDI-Public: 00763000100681
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 10/09/2020
• Device Model Number: VNMF3737C174TU
• Device Catalogue Number: VNMF3737C174TU
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 85 KG