MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; AORTO UNI-ILIAC [SUPRARENAL]

Model Number	A28-28/C75-O20 V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
Patient initially implanted with an infrarenal aortic extension and two suprarenal aortic extensions on (b)(6) 2016.The initial implant did not include a main body device due to patient having a large aneurysm and a hypogastric artery on the left located 6-8mm from the native bifurcation.On (b)(6) 2016 a follow up computed tomography (ct) showed a type 1a endoleak.The physician elected to implant an additional suprarenal aortic extension to seal the leak.The procedure was completed and there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm a type 1a endoleak.Additionally there was evidence to reasonably support the following observations; intraoperative stent migration of all three cuffs and a type 2 endoleak.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, long term antiplatelet therapy and patient anatomy.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.
Event or Problem Description
Angio: (b)(6) 2016, (b)(6) 2016 ct: (b)(6) 2016, (b)(6) 2016 us: (b)(6) 2016.

• Brand Name: AFX
• Common Device Name: AORTO UNI-ILIAC [SUPRARENAL]
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6197513
• Report Number: 2031527-2016-00586
• Device Sequence Number: 19051497
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)190315
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/17/2017

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: 03/15/2019
• Device Model Number: A28-28/C75-O20 V
• Device Lot Number: 1464247-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 03/14/2017
• 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: AORTO UNI-ILIAC [INFRARENAL]- (B)(4); AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR