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

Model Number	TV-IL1414140-J
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.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 ovation ix.Endologix was recently made aware from the physician that the patient underwent a secondary procedure for an occluded limb.The patient was reportedly lost the patient to follow-up however, was called to the er for a left limb occlusion which may have been occluded for an extended length of time because the patient revealed that there had been pain in the left leg soon after the initial procedure.The radiologist confirmed seeing the patient on (b)(6) 2017; approximately 14 months post-op.At the recent er visit, the implanting physician elected to treat the patient by fem/fem and reline flow to the patient's left leg.This secondary was reported to have occurred on (b)(6) 2018.The current patient condition is reported as fine with no pain in either leg, no evidence of any endoleak.The physician has shared that the patient will be monitored under his care for future follow-ups.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7523976
• Report Number: 3008011247-2018-00100
• Device Sequence Number: 19138727
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414140J1
• UDI-Public: +M701TVIL1414140J1/$$3190317FS12161513N
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: TV-IL1414140-J
• Device Catalogue Number: TV-IL1414140-J
• Device Lot Number: FS121615-13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR