MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Occlusion (1984); No Code Available (3191)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
During an initial implant to treat an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent, it was reported that after the deployment of the main body the pig tail catheter (non - endologix) became stuck.The physician elected to deploy the proximal extension.The pig tail catheter was then attempted to be remove but when pulled the proximal extension was pulled down causing a loss of seal.The physician was unable to recover the pig tail catheter or restore the seal.The physician then performed a laparotomy and the endografts were explanted by the physician.The physician completed the repair of the abdominal aortic aneurysm (aaa) with non - endologix devices.No further additional information or patient sequalae has been reported at this time.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported pig tail stuck, difficult to withdraw and conversion was refuted, rather post implant of the afx2 bifurcated stent graft, afx vela suprarenal and afx vela infrarenal there was a right renal artery occlusion.After multiple unsuccessful attempts to treat the occlusion a laparoscopic bypass from right renal artery to right iliac artery was completed.The afx2 devices remained implanted with a successful outcome.The reported event of the stent dislodge/displaced with cephalic movement was confirmed.The stent dislodge/displaced is most likely user related due to the extra manipulation and of the implanted afx2 stent graft to treat the occluded right renal artery.The procedure related harms identified was an additional surgical procedure (laparoscopy bypass of the right renal artery).The final patient status was in stable condition post the implant procedure.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted; therefore, no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.Corrections: g1,2: contact office- name has been updated h6: patient code ¿ remove 3191 h6: device code ¿ remove 2907 h6: result code ¿ remove 3233 h6: conclusion code ¿ remove 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8696322
• Report Number: 2031527-2019-00276
• Device Sequence Number: 11374090
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)190919
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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: 09/19/2019
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1988490-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 05/13/2020
• 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 (LN 1720817-002); VELA SUPRARENAL (LN 1956280-008); VELA INFRARENAL (LN 1720817-002); VELA SUPRARENAL (LN 1956280-008)
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 69 YR