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

Model Number	BA28-80/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	01/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices 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) 2014, a patient was initially implanted with an afx bifurcated stent graft to treat an abdominal aortic aneurysm.Approximately , 1.5 years later , a type 3a leak was identified in the patient during an angiogram by dr.(b)(6) between the main body limb and the limb extension.A secondary procedure was performed on (b)(6) 2016.During the intervention , one 25-95 proximal extension (used as a limb extension) was used to fix the leak.No additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, a type 3a endoleak is unconfirmed.Additional information include a sac growth (rcia and aorta).The most likely cause of the distal loss of seal was the reported hostile iliac anatomy.Procedure related harms and final patient disposition could not be determined due to the lack of the medical information surrounding the initial implant procedure and the secondary endovascular procedure.To date there has been no reports of further negative sequalae.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7469397
• Report Number: 2031527-2018-00279
• Device Sequence Number: 173304
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)170721
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/21/2017
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1251776019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: LIMB STENT GRAFT , VELA SUPRARENAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR