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

Model Number	TV-IL1428160-J
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Stenosis (2263); Claudication (2550)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident devices remain implanted in the patient.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially treated with the ovation ix stent graft system for an abdominal aortic aneurysm.Approximately four (4) months post-op the patient presented for a routine follow-up with possible right leg claudication.An angiogram was completed revealing a popliteal artery aneurysm with limited flow in the right leg and the right iliac limb positioned lower than the left.In addition the right iliac limb appeared to be pinched proximally.The physician elected to treat the patient with non-endologix products; self expanding stent implanted into the right iliac limb which provided adequate flow.Furthermore, the patient will undergo an additional treatment for the unrelated popliteal artery aneurysm on a later date.The patient will continue to be monitored.
Additional Manufacturer Narrative
Based on the description of the event and lack of information available to share with endologix, an independent assessment of the reported events could not be completed.Attempts for further information were made to the hospital however, were unsuccessful.The root cause for the events could not be determined.

• 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: 7930082
• Report Number: 3008011247-2018-00210
• Device Sequence Number: 13931880
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428160J1
• UDI-Public: +M701TVIL1428160J1/$$3210404FS02281825S
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 04/04/2021
• Device Model Number: TV-IL1428160-J
• Device Catalogue Number: TV-IL1428160-J
• Device Lot Number: FS022818-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/25/2019
• 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: AORTIC MAIN BODY - FS01118-64; ILIAC LIMB - FS022818-25; ILIAC LIMB - FS030518-22; AORTIC MAIN BODY - FS01118-64; ILIAC LIMB - FS022818-25; ILIAC LIMB - FS030518-22
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR