MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number	BEA28-110/I16-30
Medical Device Problem Codes	Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Renal Failure (2041); Thrombus (2101); Stenosis (2263); Blood Loss (2597)
Date of Event	10/20/2016
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.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2016 with a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.On (b)(6) 2016 a follow up showed the patient had a thrombus midway through the graft.The physician is going to monitor, a secondary intervention has not been scheduled or planned.The patient is in stable condition.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm intra-stent mural thrombus.Additionally there was evidence to reasonably support the following observations; post initial implant (recovery)-acute renal failure, upper gastrointestinal bleeding/anemia, and endoscopy.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; antiplatelet therapy, anticoagulation therapy, existing duodenal ulcerative disease, pre-existing coronary artery disease, anemia, atrial fibrillation, and patient anatomy.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not available for further investigation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.There have been no additional adverse events reported for this patient.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6134834
• Report Number: 2031527-2016-00555
• Device Sequence Number: 1248516
• Product Code: MIH
• UDI-Device Identifier: 00818009014580
• UDI-Public: (01)00818009014580(17)170705
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• 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,Followup
• Report Date (Section B): 10/31/2016

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: 07/05/2017
• Device Model Number: BEA28-110/I16-30
• Device Lot Number: 1517063-023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 02/18/2017
• 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: INFRARENAL AORTO UNI-ILIAC- (B)(4); SUPRARENAL AORTA UNI-ILIAC- (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR