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

Model Number	VNMF3737C97TU
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 for the endovascular treatment of a 64mm an infra-renal aneurysm in conjunction with a non mdt device.It was noted the patient had severely diseased bilateral iliacs' throughout.It was reported during the index procedure the right iliac was pre-dilated with non mdt 7 and 8 mm balloons.After deployment of the non mdt device the physician attempted to advance the navion device (b)(4).The device would not track up so the iliac was dilated again with an 8mm balloon and although a tight fit the device did track.After deployment of the graft but before the release of the tip capture the physician felt a pop and at this point a rapid decrease in the patient's blood pressure was noted.The proximal bare springs were deployed however upon removal of the delivery system some of the patient's blood vessel were observed to be attached to the delivery system.An intra-operative arteriogram was performed and a rupture at the patients right external iliac was observed.Multiple covered stents were used in an attempt to repair the artery unsuccessfully and the physician elected to convert to an open repair of the right iliac.Ligation of the non mdt bifurcate and right internal iliac origin was performed.A follow up aortogram demonstrated thrombus within the navion graft.An additional navion graft (b)(4) was then placed using access from the left side however after the second graft deployed it appeared that the navion stent was not fully expanded.The physician stated it may have been either behind the first navion or between one of the non mdt stents/struts due to their endoskeleton design.Per the physician the cause of the event was anatomy related due to bilateral severe atherosclerotic disease.No additional clinical sequelae were reported and the patient will be monitored.

• 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: 8369968
• Report Number: 2953200-2019-00274
• Device Sequence Number: 13753985
• Product Code: MIH
• UDI-Device Identifier: 00763000100674
• UDI-Public: 00763000100674
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: VNMF3737C97TU
• Device Catalogue Number: VNMF3737C97TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR