MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-20/C55F SA
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2018
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
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and two (2) limb stent graft extensions to treat an abdominal aortic aneurysm (aaa).An additional infrarenal stent graft extension was implanted on (b)(6) 2018 to resolve a previous reported event.Approximately two (2) years post initial procedure, a type 1b endoleak was reported.The physician elected to implant a ovation limb to resolve this event.As of the date of this report, there have been no additional patient sequelae reported.Note: this patient had a previous report event that was resolved and reported under 2031527-2018-00062 in (b)(6) 2018.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and/or images but no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Correction: conclusion code: remove code 11.Device code: remove code 1354.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8166975
• Report Number: 2031527-2018-00943
• Device Sequence Number: 13997810
• Product Code: MIH
• UDI-Device Identifier: 00818009011435
• UDI-Public: (01)00818009011435(17)190503
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/16/2018

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: 05/03/2018
• Device Model Number: I20-20/C55F SA
• Device Lot Number: 1484383-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 03/07/2019
• 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: AFX2 BIFURCATED STENT GRAFT, LOT 1354807011; INFRARENAL EXTENSION, LOT 1738155012; LIMB STENT GRAFT, LOT 1484383025; SUPRARENAL EXTENSION, LOT 1472880028
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR