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

Model Number	IS20-25/C55 SA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/31/2019
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted."device iteration is afx with duraply".
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, an infrarenal extension and (2) limb extensions to treat an abdominal aortic aneurysm (aaa).Reportedly, during a 3 year routine follow up a computerized tomography (ct) identified a type 1b endoleak.The physician elected to treat with an ovation ix extender and an afx limb stent graft.Intervention went well and patient is doing fine.
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 event of a type 1b endoleak from the right common iliac artery.Procedure related harms, device, user, procedure or anatomy relatedness could not be determined with the medical records /images available for review.The final patient status was reported to be discharged home on post-operative day two following a secondary endovascular procedure.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply corrections: g1,2: contact office- name has been updated.H6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8947006
• Report Number: 2031527-2019-00392
• Device Sequence Number: 205975
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)17626
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2017
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253178054
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 05/20/2020
• 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#1298515004; LIMB STENT GRAFT, LOT#1265067015; VELA INFRARENAL, LOT#1252535024
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR