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

Model Number	S17-45
Medical Device Problem Codes	Material Fragmentation (1261); Defective Component (2292); Delamination (2904); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2016
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.Event device has not been received.
Event or Problem Description
Patient initially implanted with a bifurcated stent, and a non endologix proximal extension on (b)(6) 2016.At the completion of the initial procedure, during the closure of the access site a plastic fragment was discovered coming from the access vessel.The plastic fragment was removed by hand in one intact piece.There was no known impact to the patient.The patient is stable.
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was not completed, there was no known impact to the patient.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.

• Brand Name: AFX
• Common Device Name: INTRODUCER
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5887466
• Report Number: 2031527-2016-00402
• Device Sequence Number: 11060593
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)190426
• 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,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: 04/26/2019
• Device Model Number: S17-45
• Device Lot Number: 1461997-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2016
• Supplement Report FDA Received Date: 11/07/2016
• 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