MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
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.
Event or Problem Description
The patient was initially implanted with an afx device to treat an abdominal aortic aneurysm.During procedure, a loss of wire access was presented on the ipsilateral side and the re-advanced wire went through one of the stent struts in the main body.The physician ballooned several times to address the issue, final angio showed good seal and no endoleak present.The patient was reported as doing well.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the loss of seal was found to be user related due to the use of a non-endologix proximal extension (off-label, intentional user error) with an endologix main body.There is also a significant infrarenal angulation of 93 degrees which likely contributed to the event.The final patient disposition could not be ascertained due to a lack of medical records surrounding the event, however, there have been no further reports of patient sequelae.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7396436
• Report Number: 2031527-2018-00650
• Device Sequence Number: 1794078
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)180815
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 07/14/2018

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: 08/15/2018
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 1728695023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2018
• Supplement Date Received by Manufacturer: 07/14/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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; Disability
• Patient Age: 80 YR