MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-110/I20-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow up report will be submitted.
Event or Problem Description
Patient was initially treated in 2013 for an emergent rupture.At an unknown date, the patient returned with an aneurysm growth and two bridges were implanted.At a later unknown date, the patient was treated again for an aneurysm growth with a medtronic device.On (b)(6) 2016 the patient underwent a complete reline with afx devices.The ct performed showed continued aneurysm growth and the physician noted a possible endoleak type ii.A re-intervention has not been scheduled at this time however, the physician plans to coil off the ima, thrombin and biogel.Patient condition is asymptomatic.
Additional Manufacturer Narrative
Based on the information received at the completion of the clinical evaluation, there were substantial evidence to support the following reported events: el 2 (multiple); no evidence of a secondary endovascular procedure.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.There was no device-related issue, rather, there was a type ii endoleak from multiple areas: left lumbar artery, possibly the inferior mesenteric artery, and a rogue right renal accessory artery located near l2.These anatomical features and the inability to tolerate contrasted surveillance (cautionary product use) likely contributed to the eventual sac growth.No user-related contributing issues were identified.Procedure-related harms included: type ii endoleak.Associated clinical harms for this event included sac growth.Reportedly, there was a planned intervention to treat the endoleaks.To date, there were no reports of treatment or further negative patient sequelae, and the patient was asymptomatic.In addition, the review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.The devices remain implanted in the patient and were not returned and no evaluation was completed.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; 2 musick; irvine CA 92618
• MDR Report Key: 6915980
• Report Number: 2031527-2017-00511
• Device Sequence Number: 1312222
• Product Code: MIH
• UDI-Device Identifier: 00818009012234
• UDI-Public: (01)00818009012234(17)181118
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/06/2017

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: Physician
• Device Expiration Date: 11/18/2018
• Device Model Number: BA25-110/I20-30
• Device Lot Number: 1423303-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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 INFRARENAL-LOT: 1379598-014; AFX-LIMB-LOT: 1265067-010; AFX-LIMB-LOT: 1342610-002; VELA INFRARENAL-LOT:1379620-011; VELA SUPRARENAL-LOT: 1472866-002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR