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

Model Number	BA28-110/I20-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/03/2017
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 implanted with an afx bifurcated stent graft and vela suprarenal on (b)(6) 2015.On a later date, the physician scheduled an angiogram to diagnose a possible type 1b endoleak which would require a limb extension.The patient was asymptomatic.The completed angiogram, however, confirmed a type 2 endoleak with lumbars and an irregular dilated area distal to the initial landing zone during the index procedure.The physician decided to coil the interns and land distal with the limb for the secondary procedure.This secondary case for the patient was completed on (b)(6) 2017 and the patient was implanted with an afx limb stent graft.The physician did not report any complaints or failure against an endologix device.No devices were explanted during the re-intervention and the patient tolerated the procedure well.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was evidence to reasonably support the following observations: there was no device failure, a type ii endoleak (lumbar), and no evidence of type ib rcia.The complaint is most likely anatomy related; contributing factors for this event was most likely the lumbar arteries.The procedure related harms identified were type ii endoleak from lumbar arteries which was resolved with the non-endologix stents.The final patient status was reported to be stable post the secondary endovascular procedure.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: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445883
• Report Number: 2031527-2018-00259
• Device Sequence Number: 2156736
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)171022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2017

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: Physician
• Device Expiration Date: 10/22/2017
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1283285-029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2017
• Supplement Date Received by Manufacturer: 06/03/2017
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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: AFX-VELA SUPRARENAL - LOT 1252484-019; AFX-VELA SUPRARENAL - LOT 1252484-019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR