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

Model Number	BA28-110/I20-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/09/2018
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, endologix was made aware of a possible endoleak.During feb (exact date unknown) ct scan, a possible endoleak was discovered on patient.With that finding added to the sac expansion of ~ 2cm's, md planned an intervention for assessment and possible treatment.It was at the intervention on (b)(6) 2018 that the "bulge" was discovered, but very distal to where the possible endoleak was in the feb ct.As the md wasn't certain where, or if, a type 1 was the cause of the sac expansion, he decided to re-line on (b)(6) 2018.The reline procedure included an additional bifurcation.It was reported at the final angio there was no "bulge" and no evidence of endoleak.
Additional Manufacturer Narrative
Due to the lack of receipt of relevant medical records and/or images, clinical evaluations were unable to confirm the reported event after several attempts to retrieve them.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not be returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.(suspect medical device) operator of device: please remove physician and add health professional.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7397945
• Report Number: 2031527-2018-00231
• Device Sequence Number: 18849385
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/09/2018

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: 10/22/2017
• Device Model Number: BA28-110/I20-30
• Device Catalogue Number: F00660
• Device Lot Number: 1283285016
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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 1278767014
• Outcome Attributed to Adverse Event: Required Intervention