MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-60/I16-40
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation as it remains in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The primary procedure was performed on (b)(6) 2018.An afx2 bifurcated stent graft and two axf limb stent grafts were implanted.During a follow-up visit a type ib endoleak was identified.The patient was asymptomatic.The type ib was sealed with an iliac extension on (b)(6) 2018.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the information received, clinical assessment confirmed the reported type ib endoleak from the left common iliac artery (lcia).The complaint is user related (off-label case).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 in stable condition post the secondary endovascular procedure.Additionally, clinical assessment determined that there was evidence to reasonable suggest lcia sac growth occurred that was not included in the reported event.The sac growth was discovered on (b)(6) 2018 during review of the 3month post implant ct scan.A definitive root cause was not determined; however, a contributing factor of the type ib endoleak was off label use in the iliac anatomy.The device was not be returned for evaluation.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: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7858266
• Report Number: 2031527-2018-00709
• Device Sequence Number: 16501702
• Product Code: MIH
• UDI-Device Identifier: 00818009014740
• UDI-Public: (01)00818009014740(17)180503
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/09/2018

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: Health Professional
• Device Expiration Date: 05/03/2018
• Device Model Number: BEA25-60/I16-40
• Device Lot Number: 1682950005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/26/2018
• 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 LIMB STENT GRAFT (LN 1298058011); AFX LIMB STENT GRAFT (LN 1645703001)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR