MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I16-40
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Pain (1994)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.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.On (b)(6) 2017 the patient began experiencing pain in the left leg.On (b)(6) 2017, the patient came in emergently with left leg pain.The physician identified a left iliac limb occlusion.The physician completed a thrombectomy to resolve the issue.The patient is reported to be doing well post procedure.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, a clinical assessment was able to confirm an occlusion.The most likely cause of the occlusion within the device was the off-label iliac and aortic anatomy (intentional user error).The pre-existing occlusive aorto-iliac anatomy likely contributed to this event.No procedure-related contributing issues or harms could be determined due to the lack of medical documentation.The final patient disposition could not be determined; there were no reports of further negative patient sequelae reported.The event device remains implanted in the patient and was not available 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: contact information updated with current contact for endologix.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6878957
• Report Number: 2031527-2017-00474
• Device Sequence Number: 124947
• Product Code: MIH
• UDI-Device Identifier: 00818009015013
• UDI-Public: (01)00818009015013(17)170415
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/22/2017

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: Health Professional
• Device Expiration Date: 04/15/2017
• Device Model Number: BEA22-60/I16-40
• Device Lot Number: 1484656-013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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: Required Intervention
• Patient Age: 38 YR