MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2018
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
The patient was initially implanted with a bifurcated stent graft and two (2) limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial procedure, a limb migration in the right iliac was identified.An intervention has been scheduled and further information is available at is time.As of the date of this report, there have been no additional patient sequelae reported.
Event or Problem Description
Additional information: the scheduled intervention has been cancelled.As of date there has been no intervention reported.At the completion of the clinical assessment, a type 3a endoleak between the bifurcated stent graft and the right limb extension was identified that was not previously 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, clinical was able to find substantial evidence to support the following events of a type 3a endoleak between the bifurcated stent graft and the right limb extension and migration of the right limb.This event is most likely user related due to the off label iliac anatomy.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.
Event or Problem Description
Additional information was received.A successful secondary endovascular procedure was completed.The physician elected to implant two (2) ovation ix extenders into the right iliac artery to treat this patient.The patient was reported as healthy.
Additional Manufacturer Narrative
Additional information received.A successful secondary endovascular procedure was confirm thru medical records.The physician elected to implant two (2) ovation ix extenders into the right iliac artery to treat this patient.The patient was reported as healthy.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.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8265465
• Report Number: 2031527-2019-00053
• Device Sequence Number: 19221124
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)190524
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Followup
• Report Date (Section B): 12/22/2018

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: 05/24/2019
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1298068-027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2018
• Supplement Date Received by Manufacturer: 03/19/2019; 05/07/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 03/27/2019; 06/04/2019
• 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-0009-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT 1594920006; LIMB STENT GRAFT, LOT 1492092017; BIFURCATED STENT GRAFT, LOT 1594920006; LIMB STENT GRAFT, LOT 1492092017
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR