MAUDE Adverse Event Report: ENDOLOGIX AFX2; VELA EXTENSION SYSTEM

Model Number	A25-25/C75-O20V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/28/2018
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
During the initial implant of an afx2 bifurcated stent the physician noted difficulty in placing the device due to vessel tortuosity.At the conclusion of the procedure there was an endoleak type iiia on angiography.The physician elected to perform touch-up on that junction portion, at this time it was noted that the cuff had migrated down and angio showed the endoleak type iiia was still present between the cuff and main body.The physician elected to conclude the procedure and monitor the patient.As of this report, no additional patient sequelae have been 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.Several attempts were made to obtain medical records and/ or images but an inadequate response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX2
• Common Device Name: VELA EXTENSION SYSTEM
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8037602
• Report Number: 2031527-2018-00827
• Device Sequence Number: 1464336
• Product Code: MIH
• UDI-Device Identifier: 00818009013576
• UDI-Public: (01)00818009013576(17)210531
• 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: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 05/31/2021
• Device Model Number: A25-25/C75-O20V
• Device Lot Number: 1936867009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: AFX2 BIFURCATED-LOT: 1943035008; AFX2 BIFURCATED-LOT: 1943035008
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR