MAUDE Adverse Event Report: ENDOLOGIX 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); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 an afx bifurcated stent graft, an afx vela infrarenal, and three afx limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately, 4 (four) years post initial procedure, a routine follow-up identified iliac aneurysm enlargement of 5cm and a type ib endoleak.Re-intervention was successfully completed with implant of ovation ix extender and two ovation ix iliac limbs occluding both iliac aneurysms.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft, an afx vela infrarenal, and three afx limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately, 4 (four) years post initial procedure, a routine follow-up identified iliac aneurysm enlargement of 5cm and a type ib endoleak.Re-intervention was successfully completed with implant of ovation ix extender and two ovation ix iliac limbs occluding both iliac aneurysms.Additional information: during the investigation of this event, the type ib endoleak event is refuted, rather there was a type iiia endoleak of the infrarenal extension and iliac stent in the right common iliac artery.There was also separation of the bifurcated stent graft and iliac stent in the left common iliac artery without evidence of an endoleak.
Additional Manufacturer Narrative
An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the type ib endoleak was refuted, rather there was a type iiia endoleak of the infrarenal extension and iliac stent in the right common iliac artery.Clinical assessment identified that there was also separation of the bifurcated stent graft and iliac stent in the left common iliac artery without evidence of an endoleak, the sac growth of the right common iliac artery is unconfirmed due to a lack of relevant and complete imaging provided.The most likely causation for these events is user and anatomy related due to the off label nature of the right common iliac artery (concomitant product use with snorkel and use of proximal extension in iliac artery) and aorta remodeling with increase in angulation.No procedure related harms were identified.The final patient status was discharged on the second postoperative day following a secondary endovascular procedure.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents 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: 10299703
• Report Number: 2031527-2020-00205
• Device Sequence Number: 3748705
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)180619
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 06/19/2018
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1350053008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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: AFX BIFURCATED STENT GRAFT (LN 1412029012); AFX LIMB STENT GRAFT (LN 1252550009); AFX LIMB STENT GRAFT (LN 1298057007); AFX VELA INFRARENAL (LN 1390665008)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR