MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number	TV-AB2080-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Not Applicable (3189)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned for a follow up approximately 8 months post-index procedure where physician observed the presence of a type ii endoleak.The physician has elected to perform a re-intervention; however, the date of the re-intervention has not been reported/confirmed.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
There was no device issue for this event, rather there was a type ii endoleak which is an anatomy related issue.Procedure related harms and the final patient disposition could not be determined, however, it was reported that the physician successfully resolved the type ii endoleak using coils and onyx glue.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7285631
• Report Number: 3008011247-2018-00024
• Device Sequence Number: 16438489
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3190114FS121515280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS121515-28
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/07/2018
• 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: OVATION IX ILIAC LIMB: TV-IL1412120-J; OVATION IX ILIAC LIMB: TV-IL1412120-J
• Outcome Attributed to Adverse Event: Required Intervention