MAUDE Adverse Event Report: ENDOLOGIX INC. AFX 2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/24/2018
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
During the initial implant of an afx bifurcated and infrarenal extension an angio was performed and the physician noted a possible endoleak or a normal graft expansion.The physician elected to inflate an aortic balloon in the neck and the rest of the aortic portion of afx device.Through angio, it was noted that the shape of the stent changed and contrast was seen flowing outside the stent.The physician could not verify what type of leak was present and elected to conclude the procedure and monitor the patient.Patient is reported to be in good condition.
Additional Manufacturer Narrative
At the completion of the investigation, the unknown endoleak was confirmed to be a type ii endoleak dual fed from lumbar artery.The complaint is most likely anatomy related and no device failure was seen.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be stable.Devices remain implanted in the patient and were not returned, no evaluation 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.(b)(4).

• Brand Name: AFX 2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7282142
• Report Number: 2031527-2018-00102
• Device Sequence Number: 2117250
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)180912
• Combination Product (Y/N): N
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 09/12/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1739061006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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-LOT: 1676650-004; VELA SUPRARENAL-LOT: 1676650-004
• Outcome Attributed to Adverse Event: Other