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

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Kinked (1339); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with afx device to treat an abdominal aortic aneurysm and an aneurysm on the right common iliac with no distal neck.During this procedure, it was noted that the c-arm stopped working and the the afx introducer was placed in the right access for a longer period of time.On (b)(6) 2018, endologix was made aware that this patient had reported pain of the leg a few days earlier.The physician decided to perform an angiography and discovered that the right iliac extension was occluded and kinked.The physician elected to do angioplasty and implant a non- endologix stent in order to open the kinked portion of the iliac extension thru brachial access.The procedure was successful.The patient was reported as ok and there have been no additional patient sequelae 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 able to find substantial evidence to support the following reported finding of the right iliac limb extension being occluded and kinked.The complaint is most likely procedure related, due to the intra operative delay.The procedure related harm identified was right leg pain, which required a secondary endovascular procedure.The final patient status was reported to be stable.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7497190
• Report Number: 2031527-2018-00420
• Device Sequence Number: 239153
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)2000127
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 01/27/2020
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1645814-009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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: BIFURCATED STENT GRAFT, LOT # 1757156-002; INFRARENAL EXTENSION. LOT # 1727511-006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR