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

Model Number	BA22-80/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7153079
• Report Number: 2031527-2017-00703
• Device Sequence Number: 1174636
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)171017
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL- (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 80