MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; BIFURCATED

Model Number	BEA25-70/I16-30
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Occlusion (1984)
Date of Event	06/01/2016
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 that the patient had an initial procedure on (b)(6) 2016 with a bifurcated and suprarenal aortic extension.Subsequently, on (b)(6) 2016, the patient was taken to the hospital emergently where the physician determined there was complete graft occlusion.Physician elected to use a non-endologix device to repair.Patient also had an above knee amputation.Patient is in stable condition.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5779901
• Report Number: 2031527-2016-00336
• Device Sequence Number: 10833058
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)170317
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2016

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: 03/17/2017
• Device Model Number: BEA25-70/I16-30
• Device Lot Number: 1355831-007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 07/08/2016
• 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: Disability
• Patient Age: 83 YR