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

Model Number	VAMF3434C150TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Vascular Dissection (3160); Insufficient Information (4580)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Valiant captivia stent grafts were implanted during the endovascular treatment of a thoracic aneurysm.A valiant navion stent graft was implanted due to continued dilation of the aortic aneurysm 8 years post the index procedure it was reported approximately 8 months post the navion procedure, follow up ct demonstrated a stable small endoleak adjacent to the distal aspect of the stent graft anteriorly within the proximal descending thoracic aorta.Ct imaging 2 years post the navion implant procedure showed an increased density extending from the anterior proximal margin of the stent with extension into the inferior aspect of the excluded aneurysm sac consistent with a type i endoleak.On (b)(6) 2022 intervention was completed.Non mdt stents were implanted to resolve the endoleak.Per the physician the cause of the endoleak is undetermined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v amc3834c150tu, serial/lot #: (b)(4), ubd: 06-feb-2014, udi#: (b)(4).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
B5: additional information received: it was confirmed the the endoleak was a type ia.It was confirmed the valiant navion was implanted due to increased aortic dilation.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
B5; additional information received : it was confirmed the valiant navion stent graft was most proximal and contained the type ia endoleak 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: corelab review of ct imaging from approximately 3 months post index procedure identified a type ii endoleak.There was no stent ring enlargement observed.The maximum aortic diameter was 92.4mm.The imaging was noted as not assessable for aneurysm enlargement.Corelab review of ct imaging from approximately 2 years post index procedure identified a type ia endoleak in the valiant navion.No stent ring enlargement was observed.The maximum aortic diameter was 102mm and there was aortic enlargement of +6.5mm when compared to imaging at 3 months.Both imaging were noted as not examinable for fracture and stent ring migration due to device overlaps.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: per the operative notes received, it was clarified that the patient had aortic valve replacement and bypass from ascending aorta to left common carotid artery.Valiant captivia stent grafts were implanted in the same year.The patient subsequently developed a type ia endoleak, which was treated with a proximal extension and a non-medtronic stent in the patient's mid arch.The patient continued to have some enlargement and increasing size of a type ia endoleak.The patient was frail and not a good candidate for open redo surgery.After careful consideration, it was decided to implant a zone zero thoracic branch graft in the innominate artery to seal the type ia endoleak.Careful centerline analysis demonstrated that there was adequate landing zone between the takeoff and the extra anatomic branch of the left common carotid artery and the innominate artery.A 37 x 150 non medtronic stent graft was deployed in a zone zero configuration.The branch was placed into the innominate artery.Completion angiogram showed no evidence of endoleak.The physician also extended the prior stent graft distally by approximately 3 cm with non-medtronic stent grafts to seal a distal stent-induced intimal injury or sine.It was noted that a distal pseudoaneurysm was present and was treated with the distal stent graft extension.There was a complete re-paving of the patient's aorta from the mid descending aorta down to zone 5.Correction to d.6a implant date 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: a type ia endoleak with a 70mm thoracic aortic aneurysm was identified on cta imaging approximately 7 years an 9 months after the index procedure.Endoleak repair was performed by tevar approximately 2 months later.Section 6a: month and year valid.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.

• Brand Name: VALIANT CAPTIVIA - FF
• 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: 15815235
• Report Number: 9612164-2022-04295
• Device Sequence Number: 12537302
• Product Code: MIH
• UDI-Device Identifier: 00613994797698
• UDI-Public: 00613994797698
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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,Followup
• Report Date (Section B): 12/13/2023

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: 08/20/2014
• Device Model Number: VAMF3434C150TU
• Device Catalogue Number: VAMF3434C150TU
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 01/18/2023; 09/18/2023; 09/18/2023; 12/06/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/19/2023; 09/22/2023; 10/03/2023; 12/13/2023
• Date Device Manufactured: 08/23/2012
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White