MAUDE Adverse Event Report: ENDOLOGIX INC. INTUITRAK; BIFURCATED

Model Number 25-16-140BL

Device Problems Bent (1059); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Failure of Implant (1924); Occlusion (1984); Thrombosis (2100); Stenosis (2263)

Event Date 09/20/2016

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.Devices remain implanted in the patient.

Event Description

Patient initially implanted a bifurcated stent on (b)(6) 2009.A follow up visit showed a possible bend at the proximal end of the main body graft and stenosis in the right limb of the main body graft as well.There was no endoleak and the physician elected to implant a suprarenal aortic extension and an ovation limb extension to resolve the issue.The patient is stable.

Manufacturer Narrative

The clinical assessment was based on patient medical records and patient images.At the completion of the clinical evaluation, based on the information received the following were confirmed; secondary procedure, and placement of an ovation in the left side for a critical stenosis.Additionally there was evidence to reasonably support the following observations; difficulty maintaining left groin hemostasis, loss of left leg pulses, heparin therapy, interventional angiogram for which a total occlusion of the left iliac to common and superficial femoral artery was noted and treated by an intra-arterial thrombosis, angioplasty, and additional non-endologix stent placement.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.Based on the information available the root cause of the reported event is unknown.

• 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: 6042396
• MDR Text Key: 57914985
• Report Number: 2031527-2016-00488
• 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: 09/20/2016

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: 04/30/2010
• Device Model Number: 25-16-140BL
• Device Lot Number: W09-1440-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2009
• 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: 86 YR