MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I16-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/28/2019
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
The patient was initially implanted with a bifurcated stent graft, an infrarenal stent graft extension and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a type 3b endoleak was identified.A secondary procedure was completed.The physician elected to reline the original implanted devices with another bifurcated stent graft and an infrarenal stent graft extension to resolve the reported event.The patient was reported as doing great post intervention.
Additional Manufacturer Narrative
At the completion of the clinical assessment, the reported type 3b endoleak was refuted, rather there were multiple type 2 endoleaks identified.The complaint is anatomy related and not device related.As this is only a type 2 endoleak anatomy and not a device related failure, a complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Corrections; please remove all previously reported information as this event is no longer reportable.
Event or Problem Description
Additional information: at the completion of the clinical assessment, the reported type 3b endoleak was refuted, rather there were multiple type 2 endoleaks identified.The complaint is anatomy related and not device related.This event is no longer a reportable event.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8479900
• Report Number: 2031527-2019-00149
• Device Sequence Number: 13707841
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)180106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 01/06/2018
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1265984-015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFRARENAL EXTENSION, LOT 1252535001; SUPRARENAL EXTENSION, LOT 1252485022; INFRARENAL EXTENSION, LOT 1252535001; SUPRARENAL EXTENSION, LOT 1252485022
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR