MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number	BA22-40/I13-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942); Occlusion (1984); Thrombosis (2100)
Date of Event	03/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device will not be returned.
Event or Problem Description
Patient initially implanted with a bifurcated stent and an infrarenal aortic extension on (b)(6) 2015.Patient presented with an occlusion of the aorta located between the bifurcated device and the renal artery.Physician elected to explant the devices and completed an aortic femoral bypass.The patient is in stable condition.
Additional Manufacturer Narrative
The clinical evaluation showed no evidence of the reported event.However, the patient did have stenosis.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.The devices were not returned for evaluation.The root cause is inconclusive, there is not enough information to determine the root cause of the reported event.Potential contributing factors include: off-label, absence of an abdominal aortic aneurysm, pan aorto-iliac stenosis with focal blood lumen diameter of 8mm (off label conditions) most likely contributed to this event.Patient factors such as concomitant treatment for renal ca, current tobacco use, and preexisting pvd/pad disease, the left fem-pop vein bypass 7 months post implant (1 month prior to the aorto-bi-femoral bypass) most likely contributed to this occlusive event.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5562038
• Report Number: 2031527-2016-00132
• Device Sequence Number: 424303
• Product Code: MIH
• UDI-Device Identifier: 00818009012159
• UDI-Public: (01)00818009012159(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2016

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: 10/31/2017
• Device Model Number: BA22-40/I13-40
• Device Lot Number: 1285397-007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 06/25/2016
• 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: 48 YR