MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL DELIVERY SYSTEM

Model Number	A25-25/C95 V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device has not been returned as of yet.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa) on an unknown date.Recently, a type 3a endoleak with separation was identified.The physician elected to treat the patient by implanting an infrarenal stent graft and an limb stent graft.This was reported under mrn# 2031527-2021-00017.Artery laceration was reported during the secondary endovascular procedure and upon removal of the introducer sheath.The physician dissected the region, sutured the damaged area, and infused blood.The patient reportedly recovered well and was transferred to icu (intensive care unit).The patient is reportedly in good condition besides an unrelated heart attack.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.Endologix received one (1) delivery system for the vela infrarenal and one (1) afx introducer for evaluation.The devices were shipped in a smaller box and double bagged.Blood and tissue residue were present upon receipt.The devices were decontaminated.A visual analysis was performed.The vela infrarenal delivery system was received inserted in the introducer.The devices were received damaged.The sheath had kinks and in-folding throughout and the tip was bent.The introducer handle end cap was unthreaded / disconnected from the handle.This is evidence that the delivery system may have had some resistance when advancing.A functional analysis was unable to be performed due to the damage identified during the visual analysis.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 event of artery laceration.This is not 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.The final patient status was reported being in good condition.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:h6: method code: remove code 4117.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL DELIVERY SYSTEM
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11198050
• Report Number: 2031527-2021-00016
• Device Sequence Number: 3780786
• Product Code: MIH
• UDI-Device Identifier: 00818009013507
• UDI-Public: (01)00818009013507(17)220702
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: A25-25/C95 V
• Device Lot Number: 2266968-012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/16/2021
• 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 INTRODUCER SYSTEM 2273104045.; AFX INTRODUCER SYSTEM 2273104044.; AFX LIMB 2275850006.; AFX INTRODUCER SYSTEM 2273104045; AFX INTRODUCER SYSTEM 2273104044; AFX LIMB 2275850006
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR