MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1422140-J
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	02/15/2018
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 8 month follow-up showed the presence of a type ib endoleak and aneurysm enlargement.A re-intervention is planned at a later date to treat the endoleak with the placement of an iliac limb extension to extend the distal seal.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
Based on the clinical assessment performed the reported type ib endoleak was refuted; rather, the clinical assessment determined that there was evidence to reasonably suggest a type iiib endoleak of the right limb stent that was not included in the event as reported.The type iiib endoleak was discovered during review of the ct from (b)(6) 2018, 10 months post implant.The complaint is most likely device related.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
The secondary procedure was performed on (b)(6) 2018.Patient was implanted with an ovation ix limb.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7331177
• Report Number: 3008011247-2018-00033
• Device Sequence Number: 151170
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422140J1
• UDI-Public: +M701TVIL1422140J1/$$3200413FS032017408
• 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): 02/15/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: TV-IL1422140-J
• Device Catalogue Number: TV-IL1422140-J
• Device Lot Number: FS032017-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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-IL1422120-J.; OVATION IX MAIN BODY: TV-AB2680-J.; OVATION IX ILIAC LIMB: TV-IL1422120-J; OVATION IX MAIN BODY: TV-AB2680-J
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR