MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-110/I16-30
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	03/09/2018
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
Patient was implanted with an afx2 bifurcated and vela suprarenal in 2016.On (b)(6) 2018, we were made aware that this patient had a possible endoleak type iii (not specified).There was no sac enlargement and the patient is reported to be doing well.Patient will undergo an angio and possible reline.There has been no additional patient sequalae reported at this time.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefor no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following event s of a type lllb endoloeak and the additional findings of stent cage dilation during review of a post implant ct scan.The most likely cause of the type lllb endoleak and stent dilation could not be determined based on the information shared with endologix to review.The final patient status was reported to be favorable pending diagnostic testing.The clinical assessment determined that there was evidence to reasonable suggest stent cage dilation of the main body of 21% (stretched and breeched) occurred that were not included in the event as reported.The stent cage dilation was discovered on (b)(6)2018 during review of the fifteen month post implant ct scan.Procedure-related harms and the final patient disposition could not be determined due to the lack of medical information surrounding the event.There were no reports of negative patient sequelae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7403503
• Report Number: 2031527-2018-00225
• Device Sequence Number: 1950053
• Product Code: MIH
• UDI-Device Identifier: 00818009014580
• UDI-Public: (01)00818009014580(17)170705
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: Physicist
• Device Expiration Date: 07/05/2017
• Device Model Number: BEA28-110/I16-30
• Device Lot Number: 1517063034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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: VELA SUPRARENAL-LOT: 1601863005; VELA SUPRARENAL-LOT: 1601863005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR