MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-60/I13-40

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problems Failure of Implant (1924); Occlusion (1984)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

Endologix was informed that a revision was performed on an afx graft placed in 2017 for an occluded limb.Patient presented this week with a totally occluded left common iliac that extended into her left external iliac.She was treated with ekos to remove the clot then a self expanding stent was placed in her left external iliac artery.It is not clear as to whether the graft caused the occlusion or if the culprit was distal disease.The patient is doing well and as of the date of this report, no additional patient sequelae has been reported.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7658742
• MDR Text Key: 113027012
• Report Number: 2031527-2018-00581
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)180310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/10/2018
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 1665527005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION EXTENDER-LOT: 1665527005
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR