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

Model Number	A28-28/C95 V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	07/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the investigation, based on the patient information received, the clinical evaluation was able to confirm the reported endoleak.The endoleak was determined to be a type 1a endoleak.The clinical evaluation additionally found the following potential contributing factors to the reported; off label use, current tobacco use, patient anatomy, and antiplatelet therapy.The devices remain implanted in the patient and were not available for further evaluation.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 root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event.There have been no additional adverse events reported for this patient.Devices remain implanted in the patient.
Event or Problem Description
Patient initially implanted with a bifurcated stent and a suprarenal aortic extension on (b)(6) 2013.On (b)(6) 2014 computed tomography angiogram (cta) showed aneurysm sac growth from 5.7 cm to 6.3 cm.On (b)(6) 2014 the cta showed additional aneurysm sac growth to 7 cm, no endoleak was identified.On (b)(6) 2014 a type 2 endoleak was identified and the patient underwent a coil embolization, the physician noted continued sac expansion to 8 cm.On (b)(6) 2014 the patient had an additional coiling procedure.On (b)(6) 2014 the patient had a suspected type 3a endoleak and the physician elected to implant an infrarenal aortic extension to seal the leak.On (b)(6) 2015 an unknown endoleak was identified and on (b)(6) 2015 an additional infrarenal aortic extension was placed to seal the endoleak.The procedure was completed and no additional adverse events were reported for this patient.

• Brand Name: AFX
• Common Device Name: AORTO UNI-ILIAC [INFRARENAL]
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6216668
• Report Number: 2031527-2016-00599
• Device Sequence Number: 18902078
• Product Code: MIH
• UDI-Device Identifier: 00818009013521
• UDI-Public: (01)00818009013521(17)150317
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2015

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: 03/17/2015
• Device Model Number: A28-28/C95 V
• Device Lot Number: 1164430-016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2015
• Initial Report FDA Received Date: 12/30/2016
• 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: 71 YR