MAUDE Adverse Event Report: ENDOLOGIX INC. INTUITRAK; BIFURCATED

Model Number 25-16-100BLS

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 12/13/2016

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

Patient initially implanted with a bifurcated stent and an infrarenal aortic extension on (b)(6) 2010.The patient had a follow up and the physician identified a type 3a endoleak.The physician elected to implant one non-endologix thoracic device as a bridge piece between the main body and the proximal extension to repair the separation.The physician also implanted three additional non-endologix devices to reline the initial implant.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the investigation, based on the information received the following were confirmed; endoleak type iiia and secondary procedure.Additionally there was evidence to reasonably support the following observation; mal positioned of a non-endologix stent causing stent collapse/stenosis of the main body stent which limited blood flow.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; off-label, near dual 90° angulation of the stent, and user error of mal positioned on the non-endologix stent.Unknown, there is not enough information available to determine the root cause of the reported event at this time.

• Brand Name: INTUITRAK
• 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: 6248185
• MDR Text Key: 64709127
• Report Number: 2031527-2017-00014
• Device Sequence Number: 1
• Product Code: MIH
• 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,Followup
• Report Date: 12/13/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: 25-16-100BLS
• Device Lot Number: W10-3003-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: 12/13/2016
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2010
• 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: AORTO UNI-ILIAC [INFRARENAL]- W10-2385-016
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR