MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA25-110/I20-30
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	05/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; cuff buckling (aortic stenosis) (reported in a separate report), and migration type iiib endoleak of the main body, and a diagnostic angiogram, followed by a secondary endovascular intervention.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity of the main body was the lateral movement and stent remodeling caused by the severely angulated neck.Associated clinical harms: type iiib endoleak; and, an additional endovascular procedure.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
Patient was initially implanted in 2016 with one bifurcated, one suprarenal, two infrarenal, and two limbs.It was reported on (b)(6) 2017 that the patient had a secondary at an unknown date.It during the clinical evaluation of (b)(4) (report # 2031527-2017-00511) it was discovered that on (b)(6) 2017, the patient presented with an aneurysm growth, cuff buckling, stent migration, and endoleak type iib of the main body.Patient was relined on (b)(6) 2015 and the issues were successfully resolved.There was no additional patient sequalae reported for this event.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7133987
• Report Number: 2031527-2017-00685
• Device Sequence Number: 16416849
• Product Code: MIH
• UDI-Device Identifier: 00818009012234
• UDI-Public: (01)00818009012234(17)181118
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/30/2016

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: Physician
• Device Expiration Date: 11/18/2018
• Device Model Number: BA25-110/I20-30
• Device Lot Number: 1423303004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 12/20/2017
• 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: AFX VELA INFRARENAL-LOT: 1379620-011; AFX VELA SUPRARENAL-LOT: 1472866-022; AFX-INFRARENAL-LOT: 1379598-014; AFX-LIMB STENT-LOT: 1342610-002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR