MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB EXTENSION

Model Number	I20-13/C88F SA
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Thrombosis (2100)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a bifurcated, a limb stent graft and a non- endologix stent to treat an abdominal aortic aneurysm.Vessel stenosis was noted on both access sites so the physician elected to perform the left side first.It was also noted that angioplasty was performed on both side and balloon touch up was performed.The procedure was successful.On (b)(6) 2018, endologix was made aware of a secondary procedure that was performed in mid-april (the exact date is unknown).A bypass surgery (femoral-femoral) was performed due to the right eia (external iliac artery) being occluded.Angioplasty and non- endologix bare stent was implanted to resolve this event.No further information is available at this time.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.However since it was reported that a non- endologix stent was implanted before the endologix devices were implanted, this case is considered off - label.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: LIMB EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7535731
• Report Number: 2031527-2018-00479
• Device Sequence Number: 16186940
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)180509
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2018

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: 05/09/2018
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1339100-017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2018
• Supplement Date Received by Manufacturer: 04/22/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT # 1721671-004; NON-ENDOLOGIX STENT
• Outcome Attributed to Adverse Event: Required Intervention; Disability