MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
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
Endologix was made aware of a patient that had a surgical conversion (explant) performed on (b)(6) 2018 due to thrombosis from the limbs of the device.Patient was treated off ifu for aortic occlusive disease.Patient's initial implant was done on (b)(6) 2017 by dr.(b)(6) at (b)(6) medical center.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the reported thrombosis.The complaint is most likely intentional user and anatomy related.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.The likely root cause to this event was the off label anatomy (aortoiliac occlusive disease) as well as the use of this product in the absence of an aortic aneurysm.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.The explanted device has been received; however, the investigation is not yet complete.A follow up report will be submitted upon completion of returned device evaluation.
Event or Problem Description
It was reported that the initial procedure was performed on (b)(6) 2017, and the patient was implanted with a afx2 bifurcated stent.The patient had been treated off label for aortic occlusive disease.On (b)(6) 2018, the afx2 was explanted due to thrombosis from the limbs of the device.No additional event or patient information is available.
Additional Manufacturer Narrative
Endologix received one bifurcated device for evaluation, packaged in a biohazard container with blood and tissue residue present.The bifurcated stent graft is in overall good condition; however, the graft and cage have been cut circumferentially into two pieces proximal of the first segment of the main body of the graft.The graft material of the main body and the bifurcation are free of damage or defect.The sutures at the bifurcation are intact with no separation of the limbs from the main body.The sutures at the proximal and distal ends of the implant are intact.The flow lumen appears to be mostly occluded.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7507028
• Report Number: 2031527-2018-00445
• Device Sequence Number: 1425374
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)171123
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

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: 11/23/2017
• Device Model Number: BEA22-60/I13-40
• Device Catalogue Number: F00820-68
• Device Lot Number: 1619459007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 06/07/2018; 07/10/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 07/09/2018; 08/10/2018
• 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: Required Intervention
• Patient Age: 49 YR