MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-90/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Advance (2920)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially treated with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, a type ib endoleak was detected by ct.A re-intervention was performed on (b)(6) 2018 where an afx limb extension was implanted to extend the distal seal.The patient did will intra- and post-operatively and there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of 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: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8097924
• Report Number: 2031527-2018-00871
• Device Sequence Number: 14139674
• Product Code: MIH
• UDI-Device Identifier: 00818009012272
• UDI-Public: (01)00818009012272(17)180711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 07/11/2018
• Device Model Number: BA22-90/I20-30
• Device Catalogue Number: BA22-90/I20-30
• Device Lot Number: 1371057-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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: Required Intervention
• Patient Age: 71 YR