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

Model Number BA22-80/I16-40

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 11/24/2017

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.

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.It was reported the patient had a component separation, an endoleak was not initially reported.The physician is planning on using nellix or ovation to treat the patient.A secondary procedure has not been completed or scheduled.The patient is reported to be doing good.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, clinical was unable to confirm the implant separation or the open repair due to lack of medical records.The medical records were requested on (b)(6) 2017 and were denied.The current patient status is unknown.There have been no additional adverse events reported for this patient and to date there have been no reports of further negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7153079
• MDR Text Key: 96001548
• Report Number: 2031527-2017-00703
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)171017
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 10/17/2017
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1284935-028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL- (B)(4)
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 80