MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTA UNI-ILIAC

Model Number	A28-28/C75-O20 V
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/03/2016
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
It was reported that during the initial procedure on (b)(6) 2016, the physician had a deployment issue with the bifurcated device.The deployment cord on the bifurcated device was too tight and after several attempts at pulling the cord, the cord broke.In trying to remove the device from the patient the device unintentionally deployed in a sub optimal position.Following the bifurcated stent deployment the physician deployed a proximal extension as well and was not able to achieve a seal to successfully exclude the aneurysm.It was reported the initial implants are currently not anchored properly within the aorta and there has not been a scheduled intervention at this time.
Additional Manufacturer Narrative
At the completion of the investigation, a clinical assessment was not completed due to patient medical records and images not received for evaluation.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 delivery system was returned for evaluation.The device evaluation was not able to confirm the reported event, no failure or malfunction detected.The returned device operated within specification.Due to the deployment issues associated with the reported event, final device deployment did not seal the aneurysm.The initial stents remain implanted in the patient and were not available for evaluation.There have been no additional adverse events reported for this patient.

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTA UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6046228
• Report Number: 2031527-2016-00491
• Device Sequence Number: 863629
• Product Code: MIH
• UDI-Device Identifier: 00818009013521
• UDI-Public: (01)00818009013521(17)151013
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2016

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: 10/13/2015
• Device Model Number: A28-28/C75-O20 V
• Device Lot Number: 1252151-017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• 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