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

Model Number	I20-13/C88F SA
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft, a vela suprarenal, and a limb stent graft.Approximately three (3) years post initial procedure, the patient presented with a symptomatic rupture and type iiib endoleak of the proximal segment of the right common iliac limb.However, the exact date of event is unknown.The physician elected to treat the patient by implanting an additional bifurcated afx2 device on (b)(6) 2019.The patient has been discharged.As of date, 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.At the completion of the clinical assessment, the type iiib endoleak event was unconfirmed due to a lack of relevant medical imaging/records.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were identified.The final patient status was discharged on the first post-operative day home stable following the endovascular repair 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: 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: 9292409
• Report Number: 2031527-2019-00498
• Device Sequence Number: 19382124
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)190503
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2019

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: 05/03/2019
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1298059-034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2019
• Supplement Date Received by Manufacturer: 10/13/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 06/22/2020
• 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-0009-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL: 1595136-011; AFX2 BIFURCATED STENT GRAFT: 1519368-003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR