MAUDE Adverse Event Report: ENDOLOGIX INTUITRAK; BIFURCATED STENT GRAFT

Model Number 25-16-100BL

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2018

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

The patient was initially implanted with an intuitrak bifurcated stent graft.Approximately seven (7) years post initial implant the patient had a relining of the device with an ovation device.There was no leak present and the reason for the reline is unknown at this time.As of the date of this report there have been no additional patient sequelae reported.The patient status is unknown and no additional information was provided.

Manufacturer Narrative

An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: INTUITRAK
• 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: 8057744
• MDR Text Key: 126893877
• Report Number: 2031527-2018-00856
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 25-16-100BL
• Device Lot Number: W10-3168-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR