MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX INTRODUCER SYSTEM II

Model Number	S17-45
Medical Device Problem Codes	Entrapment of Device (1212); Kinked (1339); Difficult to Remove (1528); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been received and is pending evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
During the initial implant of afx devices; a bifurcated stent and a suprarenal aortic extension, the physician had difficulty withdrawing the inner core of the suprarenal delivery system from the introducer sheath.The physician elected to remove the entire delivery system, the suprarenal inner core and the introducer sheath, from the patient.In removing the delivery system the access site sutures were pulled out.The physician implanted a non-endologix device to resolve the issue.Following the removal of the introducer sheath from the patient it was noted the tip of the sheath was damaged.The procedure was completed and the patient is reported as doing well.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, a clinical assessment and a device evaluation conclude patient anatomy may have contributed to the reported event.The most likely cause of the inability to withdraw the vela introducer was due to the cautionary product use condition of a highly calcified and tortuous iliac artery, along with a small, hostile calcified aortic blood lumen and stenosis of 1.6 cm.No user, procedure and/or other anatomy related issues could be detected due to lack of medical imaging surrounding the implant procedure.No relative off-label contributing issues or procedure related harms could be detected.The clinical harm associated with this device failure was damage to the ispi-lateral access vessels for which an additional stent was placed.Reportedly the implant procedure was successful and the patient disposition was favorable post implant.The vela delivery system for the proximal extension as well as the introducer were returned for further evaluation.The returned device evaluation concluded the vela delivery system appeared to be in good condition with no visible signs of damage or defect.The delivery system did not contain the implant.In removing the delivery system from the introducer sheath there were no difficulties.In assessing the introducer device the handle was free from damage and/or defect.The introducer sheath was observed to have kinking and was collapsed in several places.The kinks in the sheath were most likely caused due to the anatomy of the patient.The kinks in the sheath of the introducer prevented the tip of the delivery system form being withdrawn through the sheath.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: AFX INTRODUCER SYSTEM II
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6840506
• Report Number: 2031527-2017-00446
• Device Sequence Number: 18996602
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)2005002
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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 Model Number: S17-45
• Device Lot Number: 1682487-019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR