MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A28-28/C75V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2017
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 a bifurcated stent and two infrarenal aortic extensions.At the completion of the implant procedure there was an endoleak remaining.The observed leak was diagnosed as a potential type 3b endoleak of the infrarenal aortic extension or a type 2 endoleak.The patient has not had a secondary procedure and has not been scheduled for a secondary procedure at this time.There have been no additional adverse events reported for this patient and the patient is reported to be doing well post procedure.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm an unknown endoleak coming from the proximal extension.The imaging received showed the proximal leak prior to the second proximal extension being implanted.It is unknown if the leak was resolved after the placement of the second proximal aortic extension.The most likely cause of the unknown endoleak could not be determined with the imaging provided.An endoleak was seen in the proximal left lateral aspect of the graft, but the source of the leak could not be identified.Devices remain implanted in the patient and were not returned for further investigation.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6840189
• Report Number: 2031527-2017-00441
• Device Sequence Number: 637539
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)200602
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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: 06/02/2020
• Device Model Number: A28-28/C75V
• Device Lot Number: 1699952-012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/16/2017
• 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
• Patient Age: 80 YR