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

Model Number	VNMC4040C175TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Renal Failure (2041); Insufficient Information (4580)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: vnmc4040c95tu, serial/lot #: (b)(4), ubd: 09-oct-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant navion stent grafts were implanted during an endovascular procedure for the treatment of a thoracic aortic aneurysm.It was reported the patient returned for a 6-month follow-up ct where an endoleak at mid aortic sac was observed.Two days later the patient underwent a left renal angiogram showing the graft had become dislodged from the left renal artery leaving behind the self expanding stent so a type ic endoleak was noted.The physician implanted a non-mdt renal stent into the left renal artery 2 days later. completion angiogram showed good seal and good flow to the remaining left kidney.It was noted that at the initial index procedure, the bridging stent was placed an inadequate distance into left renal artery to try and save lower pole branch (patient has 1 working kidney).This did not have enough purchase to secure graft into place and stent graft became dislodged leaving behind the self expanding stent and type ic endoleak.At the re-intervention procedure , the physician sacrificed the lower pole branch and was able to obtain good seal and distance within left renal artery. follow up appointment on post-operative day 197 showed the stent to be in good position.It was said the patients creatinine levels did increase to 1.5 which is consistent with losing part of the kidney and renal function.This was treated conservatively.A per the physician the cause of the event was device related.  no additional clinical sequelae was provided and the patient is fine.
Additional Manufacturer Narrative
Updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Core lab review of ct imaging from approximately 5 months post index procedure observed no endoleak, fracture, stent ring enlargement or stent ring migration.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: 13583246
• Report Number: 9612164-2022-00739
• Device Sequence Number: 20244981
• Product Code: MIH
• UDI-Device Identifier: 00763000101107
• UDI-Public: 00763000101107
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 02/06/2021
• Device Model Number: VNMC4040C175TU
• Device Catalogue Number: VNMC4040C175TU
• 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: 02/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022; 05/28/2024
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/04/2022; 06/26/2024
• Date Device Manufactured: 02/07/2019
• 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 H10...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female