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

Model Number BA25-100/I16-40

Device Problem Collapse (1099)

Patient Problems Failure of Implant (1924); Stenosis (2263)

Event Date 04/11/2017

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 surgical graft at an unknown date.It was reported the patient had an unknown issue and the physician elected to implant and an afx bifurcated device to resolve the issue.Due to the use of the bifurcated device in a pre-existing implant the procedure is an off label case.At the one month follow up for this patient, compression of the bifurcated stent was observed.There was no endoleak observed and the patient was asymptomatic.The physician elected to implant a balloon expandable stent inside the compressed area for further support.The patient is reported to be doing well.

Manufacturer Narrative

An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, related patient harms and patient disposition could not be independently assessed.However, the most likely cause of the stent collapse was the off label use of the stent within a preexisting surgical stent with a diameter of 16 mm.Revision of any stent was a cautionary product use condition that likely contributed to the stent collapse as well.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• 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: 6562338
• MDR Text Key: 74985927
• Report Number: 2031527-2017-00224
• 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: IT
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

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: 04/08/2018
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1252304-037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention