MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-20/C55F SA
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.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 with the afx2 abdominal aortic aneurysm stent on (b)(6) 2016 for an iliac occlusive case.Approximately two (2) years post initial procedure, a 90% stenosis in the left common iliac was detected by angiogram with no kink in the graft.Endologix became aware of the reported adverse event and product problem on (b)(6) 2018.The physician plans to treat the patient by expanding the occluded limb with a 10x4 balloon.
Event or Problem Description
Additional information received confirming that the patient was further treated for a pre-existing iliac occlusive disease; the physician elected to implant expandable stents in the limbs of the main body on an unknown date.A week later, the previous stenosis in the left common iliac was confirmed resolved.
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 an inadequate response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.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.Correction: b1; h6: remove product problem.Remove conclusion code 11.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7877531
• Report Number: 2031527-2018-00713
• Device Sequence Number: 2076432
• Product Code: MIH
• UDI-Device Identifier: 00818009011435
• UDI-Public: (01)00818009011435(17)190809
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 08/09/2019
• Device Model Number: I20-20/C55F SA
• Device Lot Number: 1358991-011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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:1358991-009; AFX-LIMB STENT GRAFT:1358991-012; AFX2-AFX2 BIFURCATED STENT GRAFT:1354929-008; AFX-LIMB STENT GRAFT:1358991-009; AFX-LIMB STENT GRAFT:1358991-012; AFX2-AFX2 BIFURCATED STENT GRAFT:1354929-008
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR