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

Model Number	BA22-80/I16-40
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluations was unable to find substantial evidence to support the following reported events; off label use of non-endologix products, iliac and stent occlussion, iliac and stent occlusion (all components), successful thrombectomy and addition of 2 more non endologix stents from proximal to distal ends of right limb.The most likely cause of the occlusion within the stent of the main body and right limb extension(report #2031527-2017-00669) was related to the off label aorto-iliac anatomy.Procedure related harms and the final patient disposition could not be determined due to a lack of medical records.There have been no further reports of negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
During the initial implant, it was reported that the physician implanted a gore excluder leg on the right external iliac artery to the common iliac artery then the afx was implanted above the excluder leg, lastly afx proximal extension was implanted.About 8 months post implant, ct showed thrombotic occlusion of the right external iliac artery to the common iliac artery.The physician elected to perform a thrombectomy and placed a new gore viabahn.It was noted by the physician that the thrombosis was due to patient anatomy and access vessel and was not a device related issue.There has been no additional patient sequalae reported at this time.During the clinical evolution of this case on (b)(6) 2018, it was discovered that there was also occlusion in the leg of the bifurcation along with the previously reported limb extension.(report# 2031527-2017-00669).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7451207
• Report Number: 2031527-2018-00370
• Device Sequence Number: 172560
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)191027
• 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: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 05/06/2019
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1605765012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/23/2018
• 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-CUFF/LIMB-LOT: 1453283023
• Outcome Attributed to Adverse Event: Required Intervention