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

Model Number	BA28-110/I20-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices remain in the patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
A secondary procedure was performed on xx/xx/xxxx, for an unknown reason.A afx2 bifurcated stent graft and a afx vela suprarenal were implanted.No additional event or patient information is available.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events: type ib endoleak lcia and a secondary endovascular procedure.However , refuted events include the endoleak resolved after secondary endovascular procedure and anendoleak in rcia.Additional findings establish that on (b)(6) 2018, a follow up ct scan showed a persistent endoleak.The most likely cause of the loss of seal could not be determined due to a lack of relevant imaging.There were no procedure related harms identified.The patient was discharged home on the third post operative day in stable condition.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.This complaint is not capa eligible at this time.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: 7444216
• Report Number: 2031527-2018-00341
• Device Sequence Number: 1095322
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)180519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: Physician
• Device Expiration Date: 05/19/2018
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1342785010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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: AFX VELA SUPRARENAL (LN 1252492026)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR