MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2017

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 with a bifurcated stent on (b)(6) 2014.It was reported the physician identified a type 1a endoleak.It is unknown if the patient has had a secondary intervention.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

The loss of seal involved a non endologix device, therefore, there is no endologix device related event, and no associated harms.Correction: remove all endologx product specification.Remove release date.Remove product problem.

Event Description

At the completion of clinical review of available data, there was evidence to support the endoleak type ia involved a non endologix device, therefore, there is no endologix related device related event, and no associated harms.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6574368
• MDR Text Key: 75399515
• Report Number: 2031527-2017-00248
• 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: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1044810-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2012
• 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): Other
• Patient Age: 75 YR