MAUDE Adverse Event Report: TRIVASCULAR, INC. OVATION IX AORTIC BODY STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM

Model Number	TV-IL1418120-J
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Rupture (2208)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Upon deployment of the left iliac limb stent graft in the presence of significant tortuosity and calcium in the left common iliac artery, the patient experienced a drop in blood pressure, and extravasation was noted outside the left iliac limb stent graft indicative of a potential rupture of the left common iliac artery.It was noted that a laparotomy was performed to explore the origin of the extravasation; however, the origin could not be confirmed.An additional iliac limb extension was placed extending down to the external iliac artery, followed by the placement of a balloon expandable stent within the left iliac limb stent graft successfully resolving the extravasation.The aneurysm was successfully excluded at the conclusion of the implant procedure.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The root cause of the emptying of the fill polymer syringe (fluid leak), indicative of a potential intravascular leak of fill polymer, and subsequent patient hypotension could not be definitively determined; however, a potential cause for this type of event is likely related to a potential compromise in the stent graft fill channel integrity and/or a compromise in the mating junction of the delivery system and stent graft.Based on a review of the returned device, there was no evidence of a compromised in the fill polymer fluid path or the mating fill tube component of the delivery system/ aortic body stent graft fill tube that would indicate a loss of polymer from the delivery system.All remaining components on the delivery system appeared as expected with no evidence of damage.The stent graft was not available for an evaluation of integrity as it remains implanted.A clinical assessment of this event showed that there were no procedure and/or user related factors that contributed to this event.It could not be determined if anatomical and/or off-label/cautionary product use conditions contributed to this event with the information available.The associated clinical harms for this event involved transient hypotension.The patient was discharged home in stable condition six (6) days post-op with no additional patient sequelae reported.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical/device information.(b)(4).

• Brand Name: OVATION IX AORTIC BODY STENT GRAFT SYSTEM
• Common Device Name: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 6353060
• Report Number: 3008011247-2017-00020
• Device Sequence Number: 16538464
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418120J1
• UDI-Public: +M701TVIL1418120J1/$$3191103FS05111622H
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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: Physician
• Device Expiration Date: 11/03/2019
• Device Model Number: TV-IL1418120-J
• Device Catalogue Number: TV-IL1418120-J
• Device Lot Number: FS051116-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON EXPANDABLE STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR