MAUDE Adverse Event Report: ENDOLOGIX, INC. VISIFLEX; STENT GRAFT

Model Number 28-28-75L US VISIFLEX

Device Problems Failure To Adhere Or Bond (1031); Failure to Align (2522)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/11/2015

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 the patient had a procedure on (b)(6) 2008 with a bifurcated device, and a cuff stent graft.Patient came had a follow up and the angiogram showed there was a contrast in the sac, and it also revealed that the 3a has grown since last couple of years.On (b)(6) 2015 the physician elected to realign with a bifurcated and the patient is doing fine.The patient is scheduled for follow-up in thirty days to make sure there is no leak and no contrast.

Manufacturer Narrative

Based upon the limited information, the evaluation of the reported event was inconclusive.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.Based upon the investigation, a root cause as well as a design or manufacturing issue was not identified and the result is inconclusive.

• Brand Name: VISIFLEX
• Type of Device: STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5274648
• MDR Text Key: 32963015
• Report Number: 2031527-2015-00487
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

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: 04/30/2011
• Device Model Number: 28-28-75L US VISIFLEX
• Device Lot Number: W08-0961-052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2008
• 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: 84 YR