MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994); Thrombus (2101)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an iliac artery aneurysm (outside indications of use) with the afx2 abdominal aortic aneurysm stent.Approximately three (3) months post initial procedure, the patient presented emergently with leg pain; an occluded right common iliac artery (rcia) due to thrombi with twisted legs of the bifurcated device were detected.The physician elected to treat the patient by implanting a bare-metal (non-endologix) stent in the left common iliac artery (lcia) on (b)(6) 2019, which successfully resolved the reported adverse events.The patient reportedly tolerated the re-intervention well and has been discharged.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: g1-2 contact office, g4, h6; h6 result code ¿ remove 3233, h6 conclusion code ¿ remove 11.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the additional surgical procedure (fem-fem bypass) and right common iliac artery occlusion are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the right common iliac artery occlusion is user related due to the diameters of the bilateral iliac arteries with reported tortuosity of the right iliac artery outside the indications for use.The twisting of the afx2 legs is unconfirmed.This is not consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was reported as being discharged in good condition on 08/08/2019.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8928624
• Report Number: 2031527-2019-00384
• Device Sequence Number: 2128932
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)211129
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2019

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: 11/29/2021
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 2015221-005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 10/02/2019; 12/02/2020
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 03/04/2020; 12/21/2020
• 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: AFX LIMB STENT GRAFT: 1991082-007; AFX2 BIFURCATED STENT GRAFT: 2170182-009
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR