MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number	BEA25-80/I13-40
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Ischemia (1942); Renal Failure (2041); Shock (2072)
Date of Event	12/22/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or 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
After the completion of the initial implant of a bifurcated stent and suprarenal aortic extension on (b)(6 2016 the patient had an additional fem-fem bypass procedure completed.The procedure was completed successfully and final angiogram run confirmed patient had good renal flow.The patient expired later the same day and the physician indicated the patient had mesenteric ischemia including renal failure.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm acute kidney failure and acute mesenteric ischemia.The final angiogram showed there were no endoleaks present and the renal arteries were not obstructed.There was also evidence to reasonably suggest the following observations; at implant patient had severe occlusive disease and the physician planned a fem-fem bypass with the addition of a non-endologix stent, patch angioplasty, revascularization and non-endologix stent placement in the right external and common iliac arteries, and three days post implant; acute hepatic failure, cardiac arrest, hyponatremia, surgical laparoscopy and laparotomy were observed.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, peripheral vascular disease, presence of thrombus, procedural ballooning in the proximal neck, and patient anatomy.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices were not returned for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause at this time.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6281372
• Report Number: 2031527-2017-00044
• Device Sequence Number: 10959331
• Product Code: MIH
• UDI-Device Identifier: 00818009014788
• UDI-Public: (01)00818009014788(17)170823
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/22/2017

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: 08/23/2017
• Device Model Number: BEA25-80/I13-40
• Device Lot Number: 1579613-009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 04/21/2017
• 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: Death
• Patient Age: 65 YR