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

Model Number	BA25-70/I16-30
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Fragmentation (1261); Use of Device Problem (1670); Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow up report will be submitted.
Event or Problem Description
Patient was initially implanted with a bifurcated stent and a suprarenal aortic extension on (b)(6) 2017.On (b)(6) 2017, the doctor noticed a foreign material being left inside the patient's body around left iliac artery.It appears to look like a cover of the contralateral limb stent graft and the possibility of the cover being left inside the body cannot be excluded but has not been confirmed.The patient condition is stable and asymptomatic at this point.Since paraplegia was not confirmed at the end of operation, doctors have decided to keep monitoring this patient without further operation at this point.As of date, no additional patient sequelae has been reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of foreign material inside the left iliac artery (delivery system - contralateral cover, and possibly a wire), difficult to deploy and no patient harm.The most likely cause of the difficult to deploy and the subsequent foreign body left inside the left iliac artery was unintentional user error (re-shealthing) in combination with a small, calcified bifurcation and a tortuous iliac anatomy (anatomy-related).The patient was reported as asymptomatic four months post implant.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Common Device Name: AFX BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6912236
• Report Number: 2031527-2017-00499
• Device Sequence Number: 655287
• Product Code: MIH
• UDI-Device Identifier: 00818009010100
• UDI-Public: (01)00818009010100(17)191129
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2017

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: 11/29/2019
• Device Model Number: BA25-70/I16-30
• Device Lot Number: 1619452-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2017
• Supplement Date Received by Manufacturer: 09/03/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: SUPRARENAL EXTENSION, LOT # 1654616-018
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR