MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2017, an evar was performed for a patient with abdominal aortic aneurysm.During this procedure the bifurcated stent was reported to not deploy.Since the bifurcated stent would not deploy, the physician elected to remove the stent however the stent became stuck on a non- endologix stent.Due to the stent becoming stuck, the physician elected to do an open surgery to resolve this issue.The patient was reported in stable condition and there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.A visual examination of the physical device confirms the control cord is caught on a stent strut preventing deployment of the implant.Quality engineering is unable to confirm that this is related to the manufacturing process.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events: unable to deploy main body stent due to the inability to open the outer sleeve and when attempting to remove, the cord became caught on a non-endologix right common iliac graft, the devices were explant, off label iliac diameters and a cautionary product use (non elgx stent within right common iliac).The most likely cause of the inability to deploy cannot be determined.There are a multiple contributing factors that may have cause this event to occur.The small, off label aorto-iliac anatomy, the use of a non endologix product within the right iliac artery, the manufacturing process and the cautionary product use conditions of access tortuosity, calcifications at the iliac seal zones.All of these factors by themselves or in combination of each other may have caused this event.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.Correction: device evaluated by manufacturer; update information, the device was returned and evaluated.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7183848
• Report Number: 2031527-2018-00024
• Device Sequence Number: 135319
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)180803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: 08/03/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1726314-005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR