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

Model Number VAMF4242C150TE

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Vascular Dissection (3160); Multiple Organ Failure (3261); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  Death  

Event Description

A valiant captivia (42x42x150) was implanted for the endovascular treatment of a type b dissection on an unknown date in 2013.A valiant navion stent graft was implanted distally due to disease progression approximately 7 years post the index procedure.  it was reported approximately 8 years post the index procedure ct identified stent ring enlargement (+2.8mm) and aortic enlargement (+19.2mm) on the navion stent graft.This ct was not examinable for fracture and stent ring migration due to scan quality.A type ia endoleak was aslo noted on the proximal valiant captivia navion graft.No intervention has been completed for the type ia endoleak.It was noted that the patient had open aortic surgery by the cardiovascular team on an unknown date when admitted with sine.Per the physician the cause of the type ia endoleak was due to progression of disease.The cause of the stent ring enlargement is un determined.No additional clinical sequalae was provided and the patient will be monitored.Core lab review of ct imaging from (b)(6) 2021 for the navion graft on vnmc4646c218te ((v30035195) identified no endoleak or stent fractures.Persistent stent ring enlargement of +2.7mm was observed.No stent ring displacement was identified.Persistent aortic enlargement of +18,2mm was observed when compared with ct imaging from 25-oct-2020.Core lab review of ct imaging from 02-aug-2021for the navion graft vnmc4646c218te ((v30035195) identified no endoleak or stent fractures.Persistent stent ring enlargement of +2.8mm was observed.No stent ring displacement was identified.Persistent aortic enlargement of +19,2mm was observed when compared with ct imaging from (b)(6) 2020.

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.

Manufacturer Narrative

It was clarified that the open surgery was carried out on (b)(6) 2021 because of a dissection proximally/ progressive proximal disease ¿ possibly related to valiant stent graft (implanted (b)(6) 2013) at that time due to type b dissection.Navion was implanted more distally.Per the site, this open cardiac surgery in 2021 was not related to the navion.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

It was confirmed that there was complete exclusion of the aneurysm after the valiant captiva was implanted.No sine was identified.It was reported that patient expired just over 1 year ago.The cause of death was reported to be not aortic related.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: it was confirmed during the open procedure on (b)(6) 2021 that additional devices were implanted in both the ascending and aortic arch.Post procedure complications included hemodynamic instability.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: it was clarified the intervention performed on (b)(6) 2021 was not for the type ia endoleak but for a stent-induced new entry tear at the valiant graft placed in 2013.An aortic arch and ascending replacement with a non mdt graft + reimplantation of the supra-aortic vessels with a bentall.A revision post-bleeding was also completed on (b)(6) 2021.Cardiac tamponade was diagnosed on (b)(6) 2021.It was noted that all procedures from (b)(6) 2021 may have led to the patient death and it cannot be ruled out whether the hemodynamic instability also contributed.The cause of death was due to persistent organ failure (renal, respiratory, cardiac, icu aquired illness) and the patient did not want further treatment, only comfort therapy.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
• 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: 15416164
• MDR Text Key: 306189013
• Report Number: 9612164-2022-03396
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2023

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: 09/06/2014
• Device Model Number: VAMF4242C150TE
• Device Catalogue Number: VAMF4242C150TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/19/2022; 10/18/2022; 03/02/2023; 06/05/2023
• Supplement Dates FDA Received: 10/13/2022; 10/20/2022; 03/13/2023; 06/09/2023
• Date Device Manufactured: 09/06/2012
• 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): Required Intervention; Death; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 66 KG