MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number	BEA25-80/I16-55, AFX2
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2016
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
Patient initially implanted with a bifurcated device, an infrarenal aortic extension, and five ovation limb extensions on (b)(6) 2016.After implanting the limb extensions on the left side it was discovered there was a poor seal between the bifurcated stent and the ovation limb.The physician attempted to balloon the area and it was unsuccessful at sealing the leak.Following the initial procedure the physician still identified a type 3a endoleak between the afx main body and the ovation limb extension on the left side.The physician elected to schedule a secondary procedure to seal the remaining type 3a endoleak.On (b)(6) 2016 the physician elected to implant a non-endologix stent to seal the area between the main body and the ovation limb extension, the leak persisted.An additional bifurcated device and an additional afx limb extension was then implanted to reline the original stents and seal the endoleak.Patient is stable.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5969075
• Report Number: 2031527-2016-00440
• Device Sequence Number: 1421134
• Product Code: MIH
• UDI-Device Identifier: 00818009014924
• UDI-Public: (01)00818009014924(17)170429
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/22/2016

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: 04/29/2017
• Device Model Number: BEA25-80/I16-55, AFX2
• Device Lot Number: 1356989-013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Initial Report FDA Received Date: 09/22/2016
• 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