MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; AORTO UNI-ILIAC [INFRARENAL]

Model Number	A28-28/C95
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069); Difficult to Remove (1528); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
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
During the initial implant procedure of afx devices the physician experienced difficulty withdrawing the device after the deployment of the proximal extension.When trying to remove the delivery system the nose cone broke off in the introducer device.The tip of the nose cone was stuck in the introducer lumen and when the introducer was removed the broken off piece was removed as well.There was no reported injury to the patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the reported event was confirmed through the evaluation of the returned device.A clinical review of the reported event identified the following potential contributing factors to the reported event; off label use due to patient anatomy and the use of a non-endologix stent within the bilateral iliac vessels.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.

• Brand Name: AFX
• Common Device Name: AORTO UNI-ILIAC [INFRARENAL]
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6397992
• Report Number: 2031527-2017-00104
• Device Sequence Number: 13461117
• Product Code: MIH
• UDI-Device Identifier: 00818009010322
• UDI-Public: (01)00818009010322(17)190729
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2019
• Device Model Number: A28-28/C95
• Device Lot Number: 1538741-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2017
• Supplement Report FDA Received Date: 06/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1