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

Model Number	BA28-100/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
Endologix became aware of an increased abdominal aortic aneurysm sac and suspicious endoleak on (b)(6) 2018 as reported by (b)(6).The date of event is (b)(6) 2018 based on the diagnosing cta scan.The patient was originally implanted with an afx bifurcated stent graft and afx vela suprarenal on (b)(6) 2015 by physician (b)(6) at (b)(6) center.The patient is asymptomatic.It is also unknown if re-intervention is planned.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: per eclinical documentation the sac growth and indeterminate endoleak are confirmed.In addition, a possible type ib endoleak and type ii endoleak at the right common iliac artery were discovered per post initial procedure imaging.The initial procedure was found to be on-label for a clinical trial patient, but the event relatedness is inconclusive.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Additional information received confirming the patient is asymptomatic with no re-intervention planned.In addition, the patient had a re-intervention on (b)(6) 2016 to treat a type ii endoleak and type ib endoleak with aneurysm expansion, and the physician implanted an infrarenal afx extension device; this secondary procedure was addressed per mfr report # 2031527-2016-00536.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7609361
• Report Number: 2031527-2018-00548
• Device Sequence Number: 10802362
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: Physician
• Device Expiration Date: 08/27/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1315861-022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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: AFX-INFRARENAL AORTIC EXTENSION:1319308-003; AFX-VELA SUPRARENAL - LOT 1252470-019; AFX-VELA SUPRARENAL - LOT 1252470-019
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR