MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I16-16/C88 SA
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Thrombus (2101); Rupture (2208)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices involved in this event have not be returned for evaluation.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent, and snorkel of the left internal iliac (off-label).Approximately two (2) years post initial procedure, the patient presented with abdominal pain; cta detected a contained rupture of the right iliac aneurysm and graft thrombus on the left side, with no endoleak.Also, the patient was reportedly non-compliant with follow-ups.The physician elected to treat the patient by converting to open repair on (b)(6) 2018.The patient tolerated the procedure well.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; requests were made and no response was received.As such, related patient harms, and patient disposition could not be independently assessed.This complaint is most likely user-related due to the snorkel procedure (off-label) of the left internal iliac at the initial case.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8272262
• Report Number: 2031527-2019-00055
• Device Sequence Number: 10808925
• Product Code: MIH
• UDI-Device Identifier: 00818009011404
• UDI-Public: (01)00818009011404(17)181029
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2018
• Device Model Number: I16-16/C88 SA
• Device Lot Number: 1299325-015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/16/2019
• 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: AFX-LIMB STENT GRAFT: 1361098-002; AFX-VELA SUPRARENAL: 1580144-014; AFX2-AFX2 BIFURCATED STENT GRAFT: 1526681-001; AFX-LIMB STENT GRAFT: 1361098-002; AFX-VELA SUPRARENAL: 1580144-014; AFX2-AFX2 BIFURCATED STENT GRAFT: 1526681-001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR