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

Model Number	BA28-80/I16-40
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Not Applicable (3189)
Date of Event	02/12/2018
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
Patient was initially implanted with an afx bifurcated and vela suprarenal device in 2016.During a routine follow up, the physician noted a potential endoleak type iiib with fabric billowing.Patient is reported as being fine and is currently being monitored.
Additional Manufacturer Narrative
Clinical evaluations was able to find substantial evidence to refute the reported fabric billowing with no endoleak; rather there was type ii endoleak which was treated with glue (as per still images).There was no device related failure rather there was a procedure-related type ii endoleak from the left lumbar artery.The final patient disposition could not be ascertained due to lack of medical information surrounding the secondary endovascular procedure.Reportedly, the patient is in stable condition.To date there has been no reports of further negative patient sequalae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot 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.Correction: patient codes: remove 1924.Device codes: remove 1354 & 1293.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7324535
• Report Number: 2031527-2018-00169
• Device Sequence Number: 1605218
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)170828
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/12/2018

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: Physician
• Device Expiration Date: 08/28/2017
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1251779030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 05/14/2018
• 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: 1350006-006; VELA-SUPRARENAL-LOT: 1350006-006
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR