MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	IS20-25/C55 SA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/02/2018
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 previously implanted with a bifurcated stent graft, a suprarenal stent graft extensions and a limb extension stent graft to treat an abdominal aortic aneurysm (aaa).Approximately two (4) month post initial implant, a type 1b endoleak (distal iliac leak from the left iliac) was discovered during a routine follow up.An intervention is scheduled for (b)(6) 2018.The patient is reported as stable and the have been no additional patient sequelae reported.
Event or Problem Description
A secondary procedure was completed.The physician elected to embolize the left hypo-gastric artery and implanted an ovation iliac limb extension to resolved to reported event.
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 an inadequate 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.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8030605
• Report Number: 2031527-2018-00824
• Device Sequence Number: 13791254
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)181111
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 11/11/2018
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253189-028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: BIFURCATED STENT GRAFT, LOT # 1779054-009; SUPRARENAL EXTENSION, LOT # 1745516005
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR