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

Model Number BA25-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Rupture (2208)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

Endologix became aware of an aortic rupture, abdominal aortic aneurysm growth (5cm to 10cm), and aortic neck dilation on (b)(6) 2018 as reported by physician (b)(6).The date of event is (b)(6) 2018 based on when the patient presented emergently with the rupture, reportedly due to follow-up negligence with no post-operative cta's.In addition, the physician believes that the inferior mesenteric artery (ima) t2 contributed to the aortic neck dilation.The patient was originally implanted with an afx bifurcated stent graft and vela suprarenal on (b)(6) 2014 by physician (b)(6) at (b)(6) medical center.During re-intervention, the patient was treated by implanting a medtronic thoracic cuff on (b)(6) 2018 by the reporting physician.The patient is doing well two weeks post-operative.

Manufacturer Narrative

A clinical 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 on (b)(6) 2018 and the required records were not received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The manufacturing lot review 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.(b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7565942
• MDR Text Key: 109974232
• Report Number: 2031527-2018-00515
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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: 12/31/2016
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1053291-024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-VELA SUPRARENAL - LOT 1210039-004; AFX-VELA SUPRARENAL - LOT 1210039-004
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR