MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft, a gore (non-endologix) iliac extender, and two (2) gore (non-endologix) excluder legs; initial implant was off-label due to afx2 use with non-endologix devices.During the initial implant, a type iiib endoleak was suspected per angiography which revealed a leak into the right common iliac.The physician elected to implant an additional gore (non-endologix) iliac extender and afx2 bifurcated stent graft, after which the endoleak disappeared.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported intraoperative type iiib endoleak of the right common iliac.The event is most likely user-related due to the use of concomitant non-endologix devices, which were implanted prior to the afx2 bifurcated device (off-label use).In addition, the right common iliac artery diameter was 37.6mm, but the ifu requires the diameter be 10-23mm (off-label use).The procedure-related harms for this event could not be determined, and the final patient status was not reported.These types of events will be monitored and trended as part of the quality system.Patient code; remove 1924 result code; remove 3233 conclusion code; remove 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9292418
• Report Number: 2031527-2019-00500
• Device Sequence Number: 11353392
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)200213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2020
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 2080150-009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX2 BIFURCATED STENT GRAFT: 2257586-004; GORE (NON-ENDOLOGIX) EXCLUDER LEG 12MM X 10CM; GORE (NON-ENDOLOGIX) EXCLUDER LEG 12MM X 10CM; GORE (NON-ENDOLOGIX) ILIAC EXTENDER: PLL161207J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR