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

Model Number VNMF4343C103TU

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Shock (2072); Vascular Dissection (3160); Pericardial Effusion (3271); Liver Failure (4492); Insufficient Information (4580)

Event Date 02/08/2020

Event Type  Death  

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.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.

Event Description

Valiant navion stent grafts were implanted in the endovascular treatment of a dissection. it was confirmed the stent graft v08146979 was implanted proximally.It was reported that during the index procedure, the patient was found to have a intimal defect at the proximal landing site causing a type a dissection and ia endoleak.  a ct was performed approximatley 8 months post the index procedure, which showed the type ia endoleak.Another ct  also showed the type ia endoleak and aortic enlargement at the proximal tevar site.  intervention was performed , a non mdt stent graft was placed in the aortic arch.At another intervention date a lsca bypass was performed and a non mdt aortic root graft was placed during a hemi arch replacement.  corelab reviewed ct imaging dated 10th of nov 2020; the type ia endoleak was noted on the stent graft v08146979.Ne for fractures on this stent graft due to device overlaps.No fractures were noted otherwise, no stent ring enlargement or stent ring migration.The maximum aortic diameter was 70.8mm.It was reported the patient died on an unknown date.The cause of death is unknown.  no additional clinical sequalae were provided and the patient is expired.

Manufacturer Narrative

Additional information received: it was clarified that the type ia endoleak was observed first on (b)(6) 2020 ct.The dissection and intimal defect along with the persistent type ia endoleak were observed again on ct on (b)(6) 2020.The patient was then transferred emergently for pericardial effusion and visualized dissection flag.A type a dissection repair using non mdt devices was performed.A cardiac arrest subsequently occurred in icu assessed as possibly secondary to rv failure.The patient developed liver failure due to shock and did not recover neurologically.The patient expired on (b)(6) 2020.Per the physician the subacute aortic type a dissection was assessed likely secondary to prior tevar as there was an intimal defect at the proximal tevar landing site.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.

Manufacturer Narrative

Additional information received: corelab review of ct imaging from approximately 8 months post-index procedure identified a type ia endoleak and aortic enlargement of +9mm.Corelab re-analyzed the ct imaging at approximately 9 months post index identified aneurysm enlargement of +13.5mm.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.

Manufacturer Narrative

Additional information received : corelab review of ct imaging from approximately 8 months post-index procedure did not identify any fractures, stent ring enlargement or stent ring migration.The maximum aortic diameter was 66.3mm.Corelab review of ct imaging from approximately 9 months post index procedure identified a persistent type ia endoleak.Aortic enlargement was noted both images when compared to imaging from 6 days after the index procedure.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
• Type of Device: 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: 16361006
• MDR Text Key: 309366513
• Report Number: 9612164-2023-00613
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100759
• UDI-Public: 00763000100759
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: VNMF4343C103TU
• Device Catalogue Number: VNMF4343C103TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 04/20/2023; 09/27/2023; 09/27/2023
• Supplement Dates FDA Received: 05/04/2023; 09/29/2023; 10/04/2023
• Date Device Manufactured: 10/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 93 KG