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

Model Number	BA28-120/I20-40
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	03/02/2018
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
Patient was initially implanted with an afx bifurcated and vela infrarenal device in 2015.Recently it was discovered that the patient had a indeterminate endoleak and sac growth.Patient is reported to be doing fine, the physician plans to explant the device, procedure date has not been scheduled.There has been no additional patient sequelae reported at this time.
Event or Problem Description
Subsequent to the previously submitted reports, additional information was received reporting that the afx device was explanted on approximately (b)(6) 2018.The patient was released from the hospital.No additional information is available.
Additional Manufacturer Narrative
Based on the clinical assessment performed the open repair and explant of the device is unconfirmed.An evaluation of the reported event could not be completed due to lack of receipt of relevant medical records and/or imaging.As such, event determination, off-label conditions, related patient harms and patient disposition could not be independently assessed.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the reported endoleak type iiib of main body stent and sac growth.Clinical evaluation was unable to determine that the patient in favorable condition and the pending open repair as reported.The most likely cause of the compromised stent graft integrity could not be determined due to lack of relevant medical imaging.Procedure related harms could not be determined due to a lack of relevant medical records surrounding the repair procedure.The patient is reported as being in favorable condition, pending an open repair.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot 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.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7386752
• Report Number: 2031527-2018-00206
• Device Sequence Number: 1393749
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)171021
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2018

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
• Operator of Device: Physician
• Device Expiration Date: 10/21/2017
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1283292022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/04/2018; 06/01/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/25/2018; 11/14/2018
• 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: VELA INFRARENAL-LOT: 1249730-011
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR