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

Model Number	TV-AB3480-E
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Ischemia (1942); Thrombosis (2100)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available for evaluation.
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The 1.5 year post-operative ct showed evidence of aneurysm enlargement of the suprarenal aorta.The physician elected convert the patient to open surgical repair and explant the ovation device.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the reported occlusion was found to undetermined/unknown.There were underlying irregularities within the limb lumen that were observed but the cause of these irregularities could not be determined due to lack of relevant imaging.Procedure-related circumstance(s), did not likely contribute to the reported event.Anatomical factors may have contributed to the reported occlusion, specifically the irregularities in the limb lumen.There were no user related, off-label, or cautionary product use conditions found.It was noted that the patient was discharged home four days post-op in satisfactory condition.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: OVATION PRIME 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: 6344626
• Report Number: 3008011247-2017-00019
• Device Sequence Number: 1503173
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480E1
• UDI-Public: +M701TVAB3480E1/$$3180116FS12031409$
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2017

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: 11/16/2018
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS120314-09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2017
• Supplement Date Received by Manufacturer: 01/21/2017
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: Required Intervention