MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be 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.Device iteration is afx2 with duraply.
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.
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: after further review, the initial report to patient id (b)(6) was submitted with the wrong cfn/fei # 3008011247, which is not associated with the afx product line.Therefore, a corrective initial/final report will be submitted for patient id (b)(6) with the appropriate cfn/fei # 2031527.Please see mfr.Report #2031527-2022-00278.
Additional Manufacturer Narrative
After further review, the initial report to patient id (b)(6) was submitted with the wrong cfn/fei # 3008011247, which is not associated with the afx product line.Therefore, a corrective initial/final report will be submitted for patient id (b)(6) with the appropriate cfn/fei # 2031527.Please see mfr.Report #2031527-2022-00278.This event per mfr.Report # is thus no longer reportable.

• 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: 15567780
• Report Number: 3008011247-2022-00125
• Device Sequence Number: 11458272
• 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: Other,Recall
• Type of Report: Initial,Followup
• 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): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement 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