MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX INTRODUCER SYSTEM

Model Number	S17-45
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the event has not been 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.
Event or Problem Description
The patient was initially being treated for an abdominal aortic aneurysm (aaa) with afx stent grafts.During this procedure, it was discovered that the radiopaque marker from the introducer system has become detached and was still inside of the patient.The physician attempted to remove the radiopaque marker but was unsuccessful.The physician elected to complete the procedure.Currently no patient harm has been reported and the patient is being monitored.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the returned device was completed.A visual and where possible functional analysis were performed.The analysis of the returned device shows that when the introducer sheath was cut open, the radiopaque marker was observed to be missing.In addition, the inner liner of the introducer sheath, which aids in braid and marker fixation, was observed to be damaged.No other non-conformities were noted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix was unable to confirm the reported component detachment event due to the lack of relevant medical information.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was not reported.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.Corrections: d10 device available for eval/date received; g4 awareness date ; h3 reason device not evaluated; remove data (device received and evaluated); h6 device code; remove 3190; h6 evaluation method code; remove 4114; h6 evaluation result code; remove 3233; h6 evaluation conclusion code; remove 11.

• Brand Name: AFX
• Common Device Name: AFX INTRODUCER SYSTEM
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9678722
• Report Number: 2031527-2020-00031
• Device Sequence Number: 3108124
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: S17-45
• Device Lot Number: 1735177024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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, LOT#2010597008; ILIAC EXTENSION, LOT# 2245887014; PROXIMAL EXTENSION, LOT#1726937007
• Outcome Attributed to Adverse Event: Other