MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I20-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/02/2018
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) 2016, the patient was implanted with a bifurcated stent and a suprarenal extension/ cuff to treat an abdominal aortic aneurysm.During this procedure an intraoperative type 1b endoleak was suspected.Ballooning was performed however the endoleak was still present.An angiography was performed and a type 3b endoleak was suspected.The physician elected to implant another bifurcated stent graft.Type 3b endoleak was resolved but a type 2 endoleak was observed.More ballooning was performed and the type 2 endoleak was resolved.
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.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following finding of a type 3b endoleak of the main body, another main body stent implant, resolved type 3b endoleak intra-operative.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.The procedure related harms identified were type ii endoleak from lumbar which was resolved with angioplasty.The final patient status was reported to be in stable condition.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7497184
• Report Number: 2031527-2018-00406
• Device Sequence Number: 11117048
• Product Code: MIH
• UDI-Device Identifier: 00818009015099
• UDI-Public: (01)00818009015099(17)180824
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2018

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: 08/24/2018
• Device Model Number: BEA22-90/I20-30
• Device Lot Number: 1731912-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2018
• Supplement Date Received by Manufacturer: 04/08/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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: BIFURCATED STENT GRAFT, LOT # 1751910-001; SUPRARENAL EXTENSION , LOT # 1727648-017
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR