MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following event of strut fracture of the bifurcated stent graft (main body).The most likely cause of the main body strut fracture was the aortic remodeling.To date there has been no reports of further negative patient sequelae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
At the completion of the clinical assessment on 04/23/2018 for a pervious report event, clinical was able to find substantial evidence to support the following additional finding of strut fracture of the bifurcated stent graft (main body).Previous reported event detail- (2031527-2018-00139).On (b)(6) 2015, the patient was initially implanted with a bifurcated stent, two (2) suprarenal extension and three (3) limb extensions.On (b)(4) 2018, endologix was made aware of a type 3a endoleak with limb separation.On (b)(6) 2018, the physician elected to implant three (3) 22x45 ovation extension to successfully bridge the separation.There have been no additional patient sequelae reported.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7535730
• Report Number: 2031527-2018-00482
• Device Sequence Number: 176196
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)171103
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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: 11/03/2017
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1284146-018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/22/2018
• 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: Other
• Patient Age: 64 YR