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

Model Number VNMC4040C218TJ

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

Patient Problems Anaphylactic Shock (1703); Reaction (2414); Respiratory Failure (2484)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A valiant navion throracic stent graft was attempted to be implanted in a patient for the endovascular treatment of a 63 mm size thoracic aneurysm.Right cfa was cut down to perform the thoracic endovascular aneurysm repair and vnmc4040c218tj (b)(4) was attempted to be delivered to the descending aorta via the stiff wire which was advanced to the ascending aorta.It was reported that during the index procedure, the patient had a narrow access vessel with the minimum diameter of right external iliac artery (eia) was about 6 mm, the device was delivered to the thoracic aorta without resistance.A pigtail catheter with a marker for contrast was advanced to the arch aorta, and dsa contrast was performed twice using the injector via puncture from the left common femoral artery (cfa).It was reported that the first time was a wide range from the arch aorta to the descending aorta for the purpose of determining the length of the device used, and the second time was a narrow range for the purpose of specifying the location of the left subclavian artery it was stated that after the physician confirmed the position of the left subclavian artery, during advancement of the device to the implant start position, prior to implant the device, the anesthesiologist indicated an abnormal value of the patient's respiratory function (insufficient ventilation), so deployment was discontinued.Although spo2 was normal, the ventilation value did not improve for more than 30 minutes.X-ray image was taken the left lung appeared to be pure white, but nonetheless the direct cause was unknown.As per the physician, cause of the event cannot be determined.It was indicated that it is highly possible that an anaphylactic shock had occurred.The physician stated that the stent graft was not the cause, but its verification was also difficult.

Manufacturer Narrative

Product analysis conclusion; the taper tip was slightly curved.There was no further deformation visible to the device.The reported patient issues could not be confirmed through analysis of the device.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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10612657
• MDR Text Key: 209358219
• Report Number: 9612164-2020-03726
• Device Sequence Number: 1
• Product Code: MIH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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: 07/09/2022
• Device Model Number: VNMC4040C218TJ
• Device Catalogue Number: VNMC4040C218TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR