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

Model Number	TV-AB2080-J
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The final angiogram showed the presence of a potential type ia endoleak in the presence of significant calcium within the aorta that could not be resolved following ballooning and the placement of a balloon expandable stent.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
A clinical assessment could not be completed due to lack of medical records and imaging.Based on the reported event, the most likely cause of the reported limb occlusion was determined to be anatomy related.A clinical assessment showed that the device did not likely contribute to the event.Procedure-related circumstances are not likely to have contributed to this event.Anatomical factors such as small diameter vessel at the landing zone and considerable circumferential calcification in the iliac artery likely contributed to the event.Cautionary product use conditions could not be determined.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 IX ABDOMINAL 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: 6309439
• Report Number: 3008011247-2017-00011
• Device Sequence Number: 1031709
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3191010FS05131601V
• 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): 01/11/2017

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: 10/12/2019
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS051316-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 08/09/2017
• 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: PALMAZ STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR