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

Model Number	BA28-110/I20-30
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow up report will be submitted.
Event or Problem Description
On (b)(6) 2018, endologix was made aware of a patient that had an occluded graft that needed to be fixed urgently.The graft was originally placed by dr donald akers for a rupture.The reintervention was performed to declot the graft in an open fashion on (b)(6) 2018.Physician felt it was an outflow problem with the patient and not the graft, patient is also non-ambulatory.Physician was able to restore flow and trap most of the clot and was very pleased with the outcome.
Event or Problem Description
Endologix was made aware of a patient that had an occluded graft that needed to be fixed urgently.The graft was originally placed by dr donald akers for a rupture on (b)(6)2016.The reintervention (secondary procedure) was performed by dr nelson on (b)(6)2018 , who worked to declot the graft in an open fashion.She felt it was an outflow problem with the patient and not the graft, patient was non-ambulatory.She was able to restore flow and trap most of the clot and was very pleased with the outcome.It was noted that patient tolerated the procedure and in stable condition.
Additional Manufacturer Narrative
A device failure could not be determined due to a lack of any medical records or imaging, as well as procedure related harms and the final patient disposition.Clinical was unable to confirm the reported graft occlusion or secondary procedure performed on (b)(6)2018.There have been no further reports of negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.Correction: adverse event or product problem (describe event or problem):please update.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7325921
• Report Number: 2031527-2018-00166
• Device Sequence Number: 119530
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)171014
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/13/2018

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: Physician
• Device Expiration Date: 10/14/2017
• Device Model Number: BA28-110/I20-30
• Device Catalogue Number: F00660
• Device Lot Number: 1283284018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 05/25/2018
• 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: VELA SUPRARENAL, LOT 1283253003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR