MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C95V
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft an afx vela infrarenal.After the afx vela infrarenal was deployed the tip became stuck when the physician intended to retract it into the sheath.Although the afx vela infrarenal delivery system did not appear to be stuck in the stent, it was unable to be withdrawn despite multiple attempts.Therefore, the delivery system and the sheath were removed together.Outside of the body, it was found that the sheath shaft had an accordion-like deformation.A non-endologix bare stent (8mm x 8cm) was deployed in the left external iliac artery as a dissection occurred in the intima by the gap between the sheath and the tip of vela suprarenal delivery system.The sheath was replaced with dryseal (non-endologix) and the procedure continued.The final patient status was not reported.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.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 was discarded by the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix confirms the reported device damage during use and the kinked component from the still photos.The reported vessel dissection and difficulty to withdraw are unconfirmed.This finding is moderately consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label as there was an absence of an abdominal aortic aneurysm as the sac measured at 38mm, and per the ifu it should be >50mm; however, clinical evaluation is unable to determine if this is a contributing factor.The final patient status remains unknown.The final patient status was not made available to endologix.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.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 13721611
• Report Number: 2031527-2022-00048
• Device Sequence Number: 17321009
• Product Code: MIH
• UDI-Device Identifier: 00818009013507
• UDI-Public: (01)00818009013507(17)240930
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: 09/30/2024
• Device Model Number: A25-25/C95V
• Device Lot Number: 2513658014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX INTRODUCER SYSTEM II (LN 2511121060); AFX2 BIFURCATED STENT GRAFT (LN 2482271003)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male