MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA22-80/I16-40
Medical Device Problem Codes	Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident devices have not been received for evaluation.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
Patient initially implanted with a bifurcated stent and an infrarenal aortic extension on (b)(6) 2016.On (b)(6) 2016 the patient was found to have an occlusion from thrombus in the main body of the bifurcated stent to the limb.The physician elected to explant the devices and complete an open repair.The patient is in stable condition following the secondary intervention.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information provided, a clinical evaluation was not able to confirm the reported event.There were no patient medical records or imaging studies available for review.The implanted devices were returned for further evaluation.The device investigation identified the use of a non-endologix proximal extension with the afx main body device.The device evaluation indicated the use of this proximal extension may have contributed to the reported event.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The root cause of the reported event is unknown, however, the concomitant use of non-endologix stent within an endologix stent may have led to the reported events.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6148967
• Report Number: 2031527-2016-00565
• Device Sequence Number: 407772
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)190608
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2016

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: 06/08/2019
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1297706-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 02/24/2017
• 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: INFRARENAL AORTO UNI-ILIAC- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR