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

Model Number BA25-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2018

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

An afx bifurcated and a vela suprarenal extension were implanted to treat an abdominal aortic aneurysm.The 2 year routine follow-up showed the presence of a potential endoleak; however, the type of endoleak was not reported.The patient is reported to be asymptomatic and stable, and will be scheduled for a possible re-intervention to treat the endoleak.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the reported secondary procedure.Clinical was unable to find evidence to support the indeterminate endoleak and patient condition post-secondary procedure.Additionally there was evidence to reasonably support the dilation of the main body stent dilation.The most likely cause of the loss of seal could not be determined due to lack of medical information surrounding the secondary event procedure.It was suspected that the combination of an oversized cuff contributed to the compromised stent graft integrity of the main body stent (stretched 20%) and the cause of the compromised stent graft integrity could not be determined.Procedure related harms and final patient disposition could not be ascertained.To date there has been no reports of further negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Correction: common device name.

Event Description

Ct studies: (b)(6) 2015; (b)(6) 2018.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7299638
• MDR Text Key: 101055507
• Report Number: 2031527-2018-00130
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)180408
• 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: 01/30/2018

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: Physician
• Device Expiration Date: 04/08/2018
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1252304024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2015
• 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
• Treatment: VELA SUPRARENAL-LOT: 1252475-006
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR