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

Model Number	A25-25/C75
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains 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 after deployment of the bifurcated and infrarenal aortic extension during the initial procedure on (b)(6) 2016, an angiography was performed which revealed a suspected pinhole on the aortic extension.Physician relined with an infrarenal aortic extension to correct the leak, but noted that the endoleak had only decreased so elected to treat with a protamine which did resolve the leak.Patient is in stable condition.
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was able to confirm the reported event.The clinical assessment was based on no medical records and adequate patient images.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 is unknown, there is not enough information to determine the root cause of the reported event.The event device was not returned for further evaluation.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; off label use.

• Brand Name: AFX
• Common Device Name: INFRARENAL AORTO UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5814290
• Report Number: 2031527-2016-00357
• Device Sequence Number: 669479
• Product Code: MIH
• UDI-Device Identifier: 00818009010285
• UDI-Public: (01)00818009010285
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PO40002
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2016

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: 09/16/2018
• Device Model Number: A25-25/C75
• Device Lot Number: 1379605-011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2016
• Supplement Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR