MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/13/2017
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.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An afx bifurcated stent graft, and two suprarenal cuff extensions were implanted to treat an abdominal aortic aneurysm.The bifurcated stent graft and the suprarenal cuff extension were implanted as planned, with the suprarenal cuff extension positioned just below the renal artery.The second surarenal cuff extension was successfully implanted above the terminal aorta to obtain sufficient overlap.The final angiogram showed the presence of a suspected type ib endoleak, that could not be resolved following the placement of an additional extension in each leg extending down to the external iliac artery.The procedure was concluded with no further treatment.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, a clinical assessment could not confirm the reported event.The most likely cause of the loss of seal and the inability to mitigate the aneurysm at the implant procedure could not be determined due to lack of medical information surrounding the implant procedure.The clinical assessment found the severely angulated infrarenal aorta, the tortuous iliac anatomy and/or the concomitant use of a non endologix iliac stent contributed to this event.The event devices remain implanted in the patient and were not returned for further evaluation.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Correction: updated adverse event information.Common device name updated contact information corrected to current contact.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6712595
• Report Number: 2031527-2017-00362
• Device Sequence Number: 11115625
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)180417
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: Physician
• Device Expiration Date: 04/17/2018
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1332969-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Other
• Patient Age: 88 YR