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

Model Number	BEA22-60/I13-40
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the following reported event: graft occlusion unconfirmed due to the lack of imaging demonstrating the exact area of occlusion (suspect right common iliac artery due to pre- existing thrombus and occlusion and presence of non-endologix stent).The complaint is most likely anatomy related; contributing factors include pre-existing aortic occlusive disease, thrombus, and occlusion present in the right common iliac artery prior to implantation.The clinical assessment also determined that there was evidence to reasonably suggest the presence of a non-endologix stent in the right common iliac artery occurred that was not included in the event as reported.The non-endologix stent was discovered during review of the 1 month post implant ct scan.Procedure related harms for this complaint could not be determined.The final patient status was not reported.The manufacturing lot review 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
An afx bifurcated was initially implanted.The patient presented three (3) months post-op with a graft occlusion (non-specific).As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.It is unknown if a re-intervention has been planned or completed at this time.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8236256
• Report Number: 2031527-2019-00022
• Device Sequence Number: 1887501
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)190320
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: Health Professional
• Device Expiration Date: 03/20/2019
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 1823230-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 01/10/2019
• 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: 45 YR