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

Model Number	VNMF4040C103TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Rupture (2208)
Date of Event	04/23/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v nmf4040c103tu, serial/lot #: (b)(4), ubd: 26-feb-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system was implanted in a patient in the infra-renal abdominal aorta for the endovascular treatment of a 75 mm diameter aortic aneurysm.The patient had previously been implanted with a talent abdominal stent graft system approximately nine years earlier and the navion devices were implanted for treatment of the migration of the talent bifurcated stent graft.It was reported that during the implant procedure, the cannulation of both talent gates was challenging due to the migration of the device.It was noted that no endoleak was present on the post implant angiogram, and good femoral pulses were present prior to groin closure.It was reported that approximately 30 mins after the evar, during the groin closure, pulses were lost and pressures flat-lined.An open intervention was performed immediately to identify the source of bleeding.No evident endoleaks were discovered, and a heart attack was believed to have occurred.The patient expired.As per the physician, the cause of the event could not be determined, however it was believed that an unidentified rupture of the aaa sac was the cause of the heart attack.It was confirmed that no evidence of such a rupture was identified during the open intervention.No additional clinical sequelae were reported, and the patient is deceased.
Additional Manufacturer Narrative
Correction to concomitant medical products section initial mdr: other relevant device(s) also include: product id: vnmf4040c103tu, serial/lot #: (b)(4), ubd: 15-jan-2021, 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
Fdc coded added at investigation completion.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.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8618852
• Report Number: 2953200-2019-00652
• Device Sequence Number: 245254
• Product Code: MIH
• UDI-Device Identifier: 00763000100711
• UDI-Public: 00763000100711
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: VNMF4040C103TU
• Device Catalogue Number: VNMF4040C103TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 08/07/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 05/23/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR