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

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2019
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, two (2) infrarenal stent graft extensions and (3) limb stent graft extensions to treat an abdominal aortic aneurysm (aaa).It was reported that at the index procedure, that one of the infrarenal stent graft extensions was used in the iliac limb.This is outside the indications of use (off- label).Approximately two (2) years post initial procedure, a type 3a endoleak was reported and resolved by implanting another limb stent graft extension.This event was previously reported under 2031527-2016-00093.Now, approximately five (5) years post initial procedure, a compression of the right iliac stent graft was identified on a computed tomography (ct).An intervention was completed.The physician elected to implant a non - endologix wall stent to resolved this event.The patient was reported as doing great.
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 buckling event is unconfirmed after reviewing the angiogram still photo provided.As such, procedure related harms, event determination, off label conditions, related patient harms and patient disposition could not be assessed per the clinical personal.However, it was reported that one of the infrarenal stent graft extensions was used in the iliac limb, the indications of use (off- label), therefore most likely cause this event.The final patient status was reported to be well post 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: 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: 9286436
• Report Number: 2031527-2019-00491
• Device Sequence Number: 155562
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)190112
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 01/12/2019
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1298054027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 06/17/2020
• 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 1055380-009; INFRARENAL EXTENSION, LOT 1217430-012; INFRARENAL EXTENSION, LOT 1217430-013; LIMB STENT GRAFT, LOT 1047376-016; LIMB STENT GRAFT, LOT 1055838-025; LIMB STENT GRAFT, LOT 1298054027
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR