MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Thrombosis/Thrombus (4440)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, three (3) afx limb stent grafts and one (1) afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately six (6) years post initial procedure the physician determined there is a possible type 3b and 3a endoleak.A re-intervention was completed with the implant of an afx limb stent graft, an afx vela suprarenal and an afx2 bifurcated stent graft.Reportedly, during the procedure the main body was deployed with the appearance that there was zero wire wrap, but when the physician tried to deploy the contralateral limb, he could see that there was in fact wire wrap.The physician was unable to correct this issue and elected to perform an aorto-uni iliac (aui) with a femoral-femoral bypass.The physician then deployed the suprarenal extension and the right afx limb extension without further complication.The final patient status was reported as doing fine and recovering well.Additional information : a clinical evaluation showed reasonable evidence to suggest an abdominal aneurysm enlargement of 5 mm occurred.The clinical assessment also determined there was a complete inability to cannulate the contralateral limb, leading to the conversion to an aorto-uni-iliac (aui) procedure and femoral-femoral bypass.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 the type 3a endoleak is unconfirmed.There was no clear type 3a endoleak, however, there was minimal overlap and intrastent thrombus.The type 3b endoleak and the additional endovascular procedure were confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest an abdominal aneurysm enlargement of 5 mm also occurred.The clinical assessment also determined there was a complete inability to cannulate the contralateral limb, leading to the conversion to an aorto-uni-iliac (aui) procedure and femoral-femoral bypass.These findings were discovered during an examination of operative note dated (b)(6) 2022.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 as being in stable 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.Device iteration is afx2.Reference mfr.Report # 3008011247-2022-00125 for initial report to patient id 58971, which was submitted with the incorrect cfn/fei #.Project: emdr.Emdr date due: 22-dec-2022 short description: afx2; possible endoleak type 3b and 3a, re-intervention completed.Device remains implanted.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• 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: 15955622
• Report Number: 2031527-2022-00278
• Device Sequence Number: 15279549
• Product Code: MIH
• UDI-Device Identifier: 00818009014467
• UDI-Public: (01)00818009014467(17)170301
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 03/01/2017
• Device Model Number: BEA28-80/I16-40
• Device Lot Number: 1354923-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT 1317216012.; AFX LIMB STENT GRAFT 1339099002.; AFX LIMB STENT GRAFT 1344336003.; AFX VELA SUPRARENAL 1252082010.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male