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

Model Number	VNMF3737C174TU
Medical Device Problem Codes	Leak/Splash (1354); Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Valiant captivia stent grafts were implanted during the endovascular treatment of a thoracic dissection.It was reported approximately 17 months post the index procedure an undetermined endoleak was observed.Intervention was completed where a valiant navion stent graft was implanted.Follow up cts 4 days post the intervention, and at 1 and 2 months post the intervention all noted the undetermined endoleak.It was reported the patient expired on an unknown date.Per the physician the cause of the endoleak and death is undetermined.
Additional Manufacturer Narrative
Correction to d4: the device's serial number was submitted in the lot# field on previous report.Updated h6 additional information received: it was reported that during the index procedure, a 36x36x200 valiant captivia stent graft was implanted just distal to the left subclavian artery, and extended distally with 36x36x150 valiant captivia.The endoleak was noted on imaging to be associated with the proximal device.The endoleak was noted to be type ia and was suggested to be due to inadequate seal by the physician.It was reported that a ct scan taken approximately 11 months post index procedure showed a type iiia endoleak in the superior descending aorta , due to junctional separation of modular components.A ct scan from approximately 1 year and 5 months post index procedure showed a smaller site of endoleak more superiorly in the superior descending thoracic aorta, also type iiia and a type ia endoleak.A valiant navion was used to treat these events.It was reported that during the intervention, the endograft was initially deployed too proximal.A non-medtronic balloon was used to pull stent back into zone ii (covering proximal valiant captivia device).Noted good result, seal <(>&<)> no endoleak.The endoleak was determined to be stable approximately 1.5 months after the intervention and there is no additional intervention/treatment planned for it.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.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
Additional information received: core lab review of ct imaging from 26-aug-2019 identified a new type ii endoleak on vnmf3737c174tu (v08130987).No stent fracture, stent ring enlargement or stent ring migration was identified.The max aortic diameter was noted as 56.9mm.The imaging for noted as n/a for aortic enlargment.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
Additional information received: it was reported that according to the imaging report, there was a persistent type ia endoleak in the valiant navion stent graft.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.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 16233600
• Report Number: 9612164-2023-00365
• Device Sequence Number: 12392527
• Product Code: MIH
• UDI-Device Identifier: 00763000100681
• UDI-Public: 00763000100681
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/07/2023

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: 10/03/2020
• Device Model Number: VNMF3737C174TU
• Device Catalogue Number: VNMF3737C174TU
• Device Lot Number: V08130987
• 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: 01/21/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 05/29/2023; 06/30/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 05/08/2023; 06/08/2023; 07/07/2023
• Date Device Manufactured: 10/04/2018
• 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 H10."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 81 KG