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

Model Number	TV-IL1416140-J
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Stenosis (2263); Claudication (2550)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient was experiencing claudication, and upon diagnostic angio, what appears to be thrombus or extrinsic compression on the left limb was observed.On (b)(6) 2018, ovation ix limb extensions were implanted in the left and right iliac limbs.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the clinical assessment performed confirmed the stent buckling of the superior stent margin of the left limb stent due to anatomic position; non treatment of this stenosis likely caused aortic, iliac and femoral stenosis (claudication) six months later.Procedure related harms could not be determined.The final patient disposition could not be determined.A definitive root cause cannot be determined for the reported event; however, stenosis - aortic tortuosity were found to be contributing factors.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.The clinical assessment determined that there was evidence to reasonable suggest stenosis of the femoral arteries, that were not included in the event as reported.This event was discovered (b)(6) 2018, while reviewing the event angiogram, seven months post implant.

• 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: 7951027
• Report Number: 3008011247-2018-00215
• Device Sequence Number: 16471750
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416140J1
• UDI-Public: +M701TVIL1416140J1/$$3200824FS08181764Z
• 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): 09/11/2018

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: 08/24/2020
• Device Model Number: TV-IL1416140-J
• Device Catalogue Number: TV-IL1416140-J
• Device Lot Number: FS081817-64
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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 (LN (B)(4)); OVATION IX MAIN BODY (LN (B)(4))
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR