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

Model Number	BA25-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/22/2016
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 was initially implanted with a bifurcated device, a suprarenal aortic extension, and a limb stent on (b)(6) 2015.On (b)(6) 2016 the patient was found to have a potential type 1b endoleak.On (b)(6) 2016 the patient had a subsequent endovascular procedure and the physician elected to add a limb extension to the right side, the physician also ballooned the extension after implant.An angiogram during the procedure was still showing an endoleak.The physician discovered the leak was not a type 1b but a type 3b.The physician elected to reline the original implant and added an additional bifurcated stent, and an additional suprarenal aortic extension.The patient is stable.
Additional Manufacturer Narrative
The clinical assessment was based on patient medical records and patient images.At the completion of the clinical evaluation, based on the information received, the following reported events was confirmed; endoleak type ib and type iiib and relining with a bifurcated, suprarenal and iliac limb extension.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.The devices remain implanted in the patient, therefore no evaluation was performed.Based on the information available, the root cause of the reported event is unknown.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5884919
• Report Number: 2031527-2016-00398
• Device Sequence Number: 16363460
• Product Code: MIH
• UDI-Device Identifier: 00818009011985
• UDI-Public: (01)00818009011985(17)171212
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2016

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: 12/12/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1283306-028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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: Required Intervention
• Patient Age: 76 YR