MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX 2; BIFURCATED

Model Number BEA22-90/I16-30, AFX2

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Collapse (1099); Leak/Splash (1354); Device Damaged Prior to Use (2284); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Thrombus (2101); Stenosis (2263); Claudication (2550)

Event Date 05/06/2016

Event Type  Injury  

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 Description

It was reported that during the initial implant on (b)(6) 2016, the physician noted that the bifurcated device was partially deployed in the package.He was able to use the device to complete the procedure.Subsequently, on (b)(6) 2016, the patient returned to the hospital emergently with a stent migration, stenosis, and deformity with a type ia endoleak.The next day, on (b)(6) 2016, the physician used competitor balloon and stent to correct the issue.Patient tolerated the surgery well.

Manufacturer Narrative

At the completion of the investigation, based on the information provided, the clinical evaluation was able to confirm the type 1a endoleak and stent collapse.The clinical evaluation was not able to confirm the reported stent migration.The clinical evaluation additionally identified the following contributing factors to the reported event; off label use, use of partially deployed stent, development of the inner stent thrombus and patent lumbar arteries prior to initial implant.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information available to determine the root cause of the reported event.There have been no additional adverse events reported for this patient.

• Brand Name: AFX 2
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5697495
• MDR Text Key: 46497200
• Report Number: 2031527-2016-00260
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)170311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO40002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2017
• Device Model Number: BEA22-90/I16-30, AFX2
• Device Lot Number: 1356221-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 96