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

Model Number VNMC3737C223TU

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

Patient Problems Pain (1994); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant navion stent graft was implanted in the endovascular treatment of a thoracic aortic dissection.It was reported the patient presented to ed 2 months later, with complaints of chest pain.A cta performed showed an acute type a aortic dissection involving the ascending thoracic aorta.Intervention was performed on the same date, an ascending aortic arch replacement with hemi arch using a non mdt graft was completed.The site assessed the event as possibly related to the study device and not related to the study procedure.The sponsor assessed the event as related to the device and not related to procedure.No cause was reported.No additional clinical sequalae were provided and the patient will be monitored.

Manufacturer Narrative

Additional information received; the event was assessed by the clinical events committee (cec) as not related to device or 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.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

B:5 additional information received; it was reported when the patient presented to the er they complained of palpitations on the previous day, physical examination revealed no abnormalities.Blood works did not show any rises in myocardial biomarkers.X-ray did not show any acute abnormalities.The cta taken 2 months after the index procedure, showed the stent graft to be in a stable position beginning just distal to the takeoff of the left subclavian artery.Flow was seen in the false lumen related to retrograde filling in the distal margin of the stent.It was also reported small pericardial effusion was observed.It was reported when the cta images were further reviewed, it identified a new stent induced entry tear seen on the angiogram, although it had not been previously identified.No additional clinical sequalae were reported and the patient will be monitored.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

B5.Additional information received; it was reported the event observed has been updated to false lumen perfusion.It was reported the patient was found to have a "stable endograft leak along the descending portion of the thoracic aorta" and the patient continued to experience back pain.The patient underwent an elective endovascular extension of the thoracic aneurysm graft.The sponsor assessed the event as device and procedure related but not related to the dissection.The site assessed the event as not related to the device but probably related to the procedure and possibly related to the dissection.The cec assessed the event as related to the device but not related to the 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.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
• MDR Report Key: 11243705
• MDR Text Key: 229116513
• Report Number: 9612164-2021-00358
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000260866
• UDI-Public: 00763000260866
• Combination Product (y/n): N
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2021

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: 08/27/2022
• Device Model Number: VNMC3737C223TU
• Device Catalogue Number: VNMC3737C223TU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 01/21/2021; 03/31/2021; 06/01/2021
• Supplement Dates FDA Received: 02/15/2021; 04/20/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75