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

Model Number	BA28-70/I16-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/16/2018
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 patient with an enlarged aaa (sac growth-6.9cm) from a routine follow up ct scan.It was also noted that there is evident of a type 3a and possible type 3b endoleak.The physician is planning to treat the patient with a aui device.No date for the re-intervention have been set or confirmed.Patient is currently in stable condition and will be monitored.
Additional Manufacturer Narrative
Due to the lack of medical records,clinical was unable to confirm the reported type 3a, 3b endoleak and sac growth.Thus the most likely cause of the loss and seal and compromised stent graft integrity as well as the final patient disposition could not be determined the patient was reported to be in favorable condition under surveillance.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.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7521051
• Report Number: 2031527-2018-00461
• Device Sequence Number: 13809230
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)171027
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/16/2018

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: 10/27/2017
• Device Model Number: BA28-70/I16-30
• Device Catalogue Number: F00753
• Device Lot Number: 1265923013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/25/2018
• 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: LIMB STENT GRAFT, LOT 1252614010; LIMB STENT GRAFT, LOT 1339099014; VELA SUPRARENAL, LOT 1252063020; LIMB STENT GRAFT, LOT 1252614010; LIMB STENT GRAFT, LOT 1339099014; VELA SUPRARENAL, LOT 1252063020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR