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

Model Number VNMF3737C229TU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Ischemia (1942); Pain (1994); Thrombosis/Thrombus (4440)

Event Date 12/20/2018

Event Type  Death  

Event Description

Valiant navion stent grafts were implanted during the endovascular treatment of a thoracic aortic aneurysm. the patient has a history of thoracoabdominal aneurysm with an ascending aneurysm and arch aneurysm and underwent aortic arch and vessel debranching with grafting of the arch with elephant trunk.It was reported that during the index procedure, the patient had massive blood loss and recovered to the vascular icu.During the post-operative period the patient had severe abdominal pain and returned to the or secondary to sma thrombosis and mesenteric changes of the colon.The patient underwent a colon resection , remained intubated and required multiple pressors and was transferred to the surgical icu.During the surgical icu stay the patient required multiple pressors and large volume resuscitation without response.Given the patients poor prognosis and the unlikelihood of response, the patients family elected for comfort care measures and the patient passed away on the same date from a cardiopulmonary arrest.It was reported that ct imaging was performed on the same date prior to the patients death.Corelab have reviewed this imaging and identified a type ii endoleak. fractures and srm set to 'ne' due to device overlaps.The maximum aortic diameter measured 71.6mm.No stent ring migration or displacement were noted.No additional clinical sequalae were provided and the patient is expired.

Manufacturer Narrative

Concomitant products: information references the main component of the system.Other relevant device(s) are: product id: v nmc4646c218tu, serial/lot #: (b)(6), ubd: 26-aug-2020, 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.

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.

• 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: 17787049
• MDR Text Key: 323890708
• Report Number: 9612164-2023-04274
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Report Date: 10/17/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: VNMF3737C229TU
• Device Catalogue Number: VNMF3737C229TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/16/2023
• Date Device Manufactured: 08/30/2018
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention; Death; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG