MAUDE Adverse Event Report: ENDOLOGIX AFX2; UNKNOWN

Model Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2018
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 stent graft to treat an abdominal aortic aneurysm.A notification was received on 06/14/2018 that a secondary intervention occurred on (b)(6) 2018 where a vela suprarenal extension was placed; however, information related to the reason for the intervention and the patient outcome was not provided.No further information is available at this time.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing record review could not be completed because the lot number was not provided.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.Several attempts were made to obtain medical records and images but no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: as the primary case information and device information was unable to be confirmed.
Event or Problem Description
Updated information: the primary case information and device information was unable to be confirmed therefore the device and patient information has updated to unknown.A notification was received on (b)(6) 2018 that a secondary intervention occurred on (b)(6) 2018 where a vela suprarenal extension was placed; however, information related to the patient, reason for the intervention and the patient outcome was not provided.No further information is available.

• Brand Name: AFX2
• Common Device Name: UNKNOWN
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7678348
• Report Number: 2031527-2018-00584
• Device Sequence Number: 13665098
• Product Code: MIH
• UDI-Device Identifier: 00818009014474
• UDI-Public: (01)00818009014474(17)180728
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 07/28/2018
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: Required Intervention