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

Model Number	BA25-80/I16-55
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924)
Date of Event	02/19/2016
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.
Event or Problem Description
Patient initially implanted with a bifurcated stent and a limb extension on (b)(6) 2016.Initial implant of the stent was due to emergent rupture of the iliac artery.A follow up found the patient had a type 3a endoleak, the physician elected to implant two additional limb extensions to seal the endoleak.Patient procedure was successful, patient condition is unstable due to existing disease progression.An update received on (b)(6) 2016 indicated the patient had expired.Actual patient date of death is unknown.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5510955
• Report Number: 2031527-2016-00109
• Device Sequence Number: 1135759
• Product Code: MIH
• UDI-Device Identifier: 00818009010070
• UDI-Public: (01)00818009010070(17)181120
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/19/2016

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: 11/20/2018
• Device Model Number: BA25-80/I16-55
• Device Lot Number: 1397314-013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2016
• Initial Report FDA Received Date: 03/18/2016
• 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: Death
• Patient Age: 59 YR