MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/02/2016
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.
Event or Problem Description
It was reported that the patient had an initial procedure on (b)(6) 2015 with a bifurcated stent, and suprarenal aortic extension.Subsequently, on (b)(6) 2016 physician identified a potential type 3b with aneurysm sac growth.Patient was asymptomatic.On (b)(6) 2016 the physician elected to reline the devices by implanting an additional bifurcated stent, an infrarenal aortic extension, and a limb stent graft.Patient is in stable condition.
Additional Manufacturer Narrative
At the completion of the investigation, based on the limited patient data available for review, the reported type 3b endoleak could not be confirmed.The clinical evaluation was able to confirm an unknown endoleak and a stent migration.The clinical evaluation additionally identified the following contributing factors to the reported event; off label use, patient anatomy, pre-existing thrombus in the aortic neck.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.The event devices remain implanted in the patient and were not available for further review.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event.There have been no additional adverse events reported for this patient at this time.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6010146
• Report Number: 2031527-2016-00471
• Device Sequence Number: 13802184
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)180324
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2018
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1320918-022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPRARENAL AORTA UNI-ILIAC- 1341526-003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR