MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Rupture (2208)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and two (2) suprarenal stent graft extensions to treat an abdominal aortic aneurysm (aaa).Approximately 1 year post initial procedure, during a routine follow up, a type ia endoleak was identified.Physician elected to resolved this event by implanting a suprarenal stent graft extension.The patient was reported as doing well.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and 2 suprarenal stent graft extensions to treat an abdominal aortic aneurysm (aaa).Approximately 1 year post initial procedure during a routine follow up a type ia endoleak was identified.Physician elected to treat with a suprarenal stent graft extension and the patient is doing well additional information: during the clinical assessment, migration of the suprarenal extension, sac growth of 10mm and rupture were identified that were not included in the reported event.
Additional Manufacturer Narrative
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.At the completion of the clinical assessment, the type ia endoleak event is confirmed.Migration of the suprarenal extension, sac growth of 10mm and rupture were also identified.These events were most likely due to the off-label neck anatomy.The neck was 9mm long (should be greater to or equal to 15mm) and the infarenal neck was 66 degrees (should be equal to or less than 60 degrees).The procedure related harm identified was a prolonged hospitalization.The final patient status was discharged on the eighth post-operative day following an urgent endovascular repair procedure.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.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9462349
• Report Number: 2031527-2019-00601
• Device Sequence Number: 14221158
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)181214
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 12/14/2018
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1767421010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 07/06/2020
• 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 SUPRARENAL , LOT# 1933825005; VELA SUPRARENAL, LOT# 1727242012
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR