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

Model Number	TV-AB2380
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/05/2017
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 prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned approximately one year post index procedure with abdominal pain and fever.The patient's lab report did not show any sign of infection or inflammation, however, the physician re-intervened by draining the aneurysm sac.After the draining was completed, the patient's fever and pain resolved.The patient is reported to be doing well and as of the date of this report, there have been no additional patient sequelae reported.
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned approximately one month post index procedure with abdominal pain and fever.The patient's lab report did not show any sign of infection or inflammation, however, the physician re-intervened by draining the aneurysm sac.After the draining was completed, the patient's fever and pain resolved.The patient is report to be doing well and as of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Describe event or problem - correction.

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7479689
• Report Number: 3008011247-2018-00082
• Device Sequence Number: 16472497
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380E1
• UDI-Public: +M701TVAB2380E1/$$3190519FS11061501/
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 05/19/2019
• Device Model Number: TV-AB2380
• Device Catalogue Number: TV-AB2380-E
• Device Lot Number: FS110615-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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 PRIME ILIAC LIMB: TV-IL1412140-E; OVATION PRIME ILIAC LIMB: TV-IL1418140-E; OVATION PRIME ILIAC LIMB: TV-IL1418140-E; OVATION PRIME ILIAC LIMB: TV-IL1412140-E; OVATION PRIME ILIAC LIMB: TV-IL1418140-E; OVATION PRIME ILIAC LIMB: TV-IL1418140-E
• Outcome Attributed to Adverse Event: Required Intervention