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

Model Number BA28-120/I16-40

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Torn Material (3024)

Patient Problems Failure of Implant (1924); Thrombus (2101)

Event Date 05/10/2017

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

The patient initially implanted with a bifurcated stent and a suprarenal aortic extension.A routine follow up showed a possible tear in the graft material and thrombus inside the stent.On (b)(6)2017 an angiogram was completed and the physician was unable to identify the presence of an endoleak.On (b)(6)2017 the physician elected to implant an ovation limb extension in the left iliac limb to resolve the issue.It was reported the patient was discharged from the hospital.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned, no evaluation completed.At the completion of the clinical assessment, the type 3b endoleak was refuted.Instead, this endoleak was determined to be a type 1b.Additionally, there was evidence to support the reported intragraft thrombus and the secondary procedure with implantation of an iliac extension (ovation).Although, the limb was reported to be positioned with the distal end into the vessel wall in a tortuous native anatomy, the most likely cause of the loss of seal could not be determined due to lack of relevant medical information.The final patient disposition was reported to be discharged from the hospital.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6632737
• MDR Text Key: 77274192
• Report Number: 2031527-2017-00300
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014184
• UDI-Public: (01)00818009014184(17)180602
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2018
• Device Model Number: BA28-120/I16-40
• Device Lot Number: 1341510-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• 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: 88 YR