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

Model Number	VNMF3737C97TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	02/17/2019
Type of Reportable Event	Death
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 >100mm ruptured thoracic aneurysm.It was reported during the index procedure it was noted the patient had an extremely hostile distal seal zone.The celiac was covered and the device was anchored but a persistent type ib endoleak was visible.The physician elected to implant coils into sac to induce thrombosis in the ruptured sac.The graft was extended lower to cover sma and renals however a small type ib endoleak remained at the end of the procedure.It was reported the patient expired approximately 2 weeks post the index procedure.Per the physician the cause of the type ib endoleak was anatomy related due to hostile distal seal zone.The cause of death was due to a ruptured thoracic and abdominal aortic artery.
Additional Manufacturer Narrative
Additional information received; it was confirmed that during the index procedure the graft stent was not extended to cover the sma and renal arteries.It was noted that imaging suggests the index endoleak continued to leak blood and eventually worsened to cause the patient to expire.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: 8357448
• Report Number: 2953200-2019-00243
• Device Sequence Number: 10814466
• Product Code: MIH
• UDI-Device Identifier: 00763000100674
• UDI-Public: 00763000100674
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: VNMF3737C97TU
• Device Catalogue Number: VNMF3737C97TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/12/2019
• 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; Required Intervention
• Patient Age: 63 YR