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

Model Number	BA25-100/I16-40
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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
On (b)(6) 2017, the patient was implanted with a bifurcated stent and a non-endologix stent.It was noted that there was an intraoperative type 1a endoleak that was resolved.It was reported that in (b)(6) 2017 (6 month follow up) a ct scan showed residual of an endoleak (type of endoleak was not report).On (b)(6) 2018, (1 year follow up) sac growth was noted.On (b)(6) 2018, the patient was admitted to the hospital.On (b)(6) 2018, a secondary procedure was performed.A hole in the distal edge of the bifurcated stent (type 3b endoleak) was discovered.Two (2) non- endologix stents were implanted to resolve this endoleak.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.Due to the lack of medical records / images, clinical was unable to find substantial evidence to support the following events of type 1b, 2 and type 3b endoleak (unknown if intraoperative or postoperative), sac enlargement or a successful secondary endovascular procedure.The most likely cause of the loss of seal and compromised stent graft integrity, as well as procedure related harms and the final patient disposition could not be determined due to the lack of medical records / images.The patient was reported as having a type ii endoleak (procedure related) as well as being discharged from the hospital on the fourth post operative day.There have been no further reports of negative patient sequelae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7397009
• Report Number: 2031527-2018-00228
• Device Sequence Number: 1094289
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)191012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: Health Professional
• Device Expiration Date: 10/12/2019
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1599386-006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR