MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; INTRODUCER

Model Number	S17-45
Medical Device Problem Codes	Material Fragmentation (1261); Delamination (2904); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
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.Device was not returned.
Event or Problem Description
The patient was initially implanted with a bifurcated stent and an infrarenal aortic extension on (b)(6) 2016.After the completion of the initial implant when the physician was withdrawing the delivery system there was plastic thread seen coming from the incision sight.The physician removed the plastic thread from the incision sight and did not observe any additional material in the incision sight following the procedure.The patient was stable post procedure.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the sample evaluation was able to confirm the reported event.The clinical evaluation additionally found the following potential contributing factors to the reported event; small iliac artery and stenosis at the aortic bifurcation.A patient injury was not reported.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 root cause of the reported event seems to be a manufacturing deficiency.There have been no additional adverse events reported for this patient.

• Brand Name: AFX
• Common Device Name: INTRODUCER
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6074301
• Report Number: 2031527-2016-00512
• Device Sequence Number: 794189
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)190705
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2016

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: 07/05/2019
• Device Model Number: S17-45
• Device Lot Number: 1517080-014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/24/2017
• 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: Other
• Patient Age: 74 YR