MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101); Stenosis (2263); Claudication (2550)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An afx2 bifurcated stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately 3 weeks post index procedure, the patient returned with intermittent feeling of numbness on the right leg.A ct revealed that there was infolding of the proximal extension and a thromboembolic event on the entire length of the right common iliac.A re-intervention was performed approximately one month post index procedure where physician implanted six excluder aortic extensions from the distal portion of the infrarenal extension up to just below the renal artery.The thrombus in the right iliac artery was removed and a stent was implanted.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, it was determined that the most likely cause of the loss of seal was the short segment aortic dissection just above the cuff margin; this anatomy-related (off-label) harm likely was responsible for the suboptimal position of the cuff, which then likely caused cuff in-folding that was not resolved with angioplasty at implant, and later caused a complete cuff collapse.In turn, this collapse was likely the cause of the proximal loss of seal (type ia endoleak), the aortic and right iliac occlusion, as well as the left iliac stenosis.Lastly, the most likely cause of the distal loss of seal (type ib endoleak) was a combination of retrograde filling through the left iliac arteries and/or lumbar arteries (indeterminate endoleak).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.(b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6914855
• Report Number: 2031527-2017-00502
• Device Sequence Number: 13781016
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)180417
• 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): 09/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2018
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 1677505011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/22/2018
• 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: INFRARENAL CUFFLOT#: 1642638018; INFRARENAL CUFFLOT#: 1642638018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR