MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; AFX CUFF/ LIMB EXTENSION

Model Number	BA22-80/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Occlusion Within Device (1423); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Thrombosis (2100); Thrombus (2101)
Date of Event	11/20/2017
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, endologix afx devices were implanted to treat an abdominal aortic aneurysm.On (b)(6) 2017, a type 1a endoleak due to buckling of the proximal extension was discovered.Also thrombotic occlusion was confirmed in the inner lumen.On (b)(6) 2017, a total of four (4) non-endologix stents was implanted and the endologix stent was explanted.The operation was completed without endoleak.No additional patient sequelae has been reported.
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.At the completion of the clinical assessment, clinical was only able to find substantial evidence to support the following reported event of the proximal cuff buckling.Clinical was unable to find substantial evidence to support the following reported events of type 1a endoleak, occlusion of cuff, and a secondary endovascular procedure due to the lack of relevant medical information.The most likely cause of the proximal cuff buckling, loss of seal, and occlusion of the proximal extension was likely related to the off label diameter and length of the proximal neck.Additionally, angulation seen in the proximal neck likely contributed to the event.The final patient disposition was not reported.No additional negative patient sequelae has been reported.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.(b)(4).

• Brand Name: AFX
• Common Device Name: AFX CUFF/ LIMB EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7149706
• Report Number: 2031527-2017-00699
• Device Sequence Number: 19266699
• Product Code: MIH
• UDI-Device Identifier: 00818009010315
• UDI-Public: (01)00818009010315(17)191104
• 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): 12/04/2017

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: 11/04/2019
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1611988-017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/07/2018
• 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: 76 YR