MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/01/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).An intraoperative type 1a endoleak was identified at time of implant however the physician elected not to treat at that time.A secondary procedure was completed 20 days post initial procedure.The physician elected to implanted an ovation ix stent graft extender to resolve this type 1a endoleak.It was reported that the aortic treatment was an palliative intervention as the patient was in the final stages of cancer.The patient expired seven (7) days post intervention (non-aaa related).
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 reported 1a endoleak, intervention, and death was unable to be confirmed due to the lack of relevant medical records and/or imaging available to review.However off- label neck anatomy and the proximal landing zone had thickened almost concentric calcifications (cautionary product use) that could have affected the proximal seal were identified with records provided for review.Therefore; the most likely cause of the type 1a endoleak was user and anatomy related.The intervention was due to the type 1a endoleak.The patient was reported to have expired due to terminal cancer.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.Correction: result code: remove code 3221.Conclusion code: remove code 11.Device code: remove code 3190.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8430974
• Report Number: 2031527-2019-00132
• Device Sequence Number: 1340782
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)171009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 10/09/2019
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1995743-005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 77 YR