MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-60/I16-40
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.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.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an ovation ix iliac limb to treat an iliac aneurysm.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately two (2) years post initial procedure, stent thrombosis that caused occlusion of the right afx limb of the bifurcated stent graft was identified.A open repair was completed with a non-endologix, bypass graft.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an ovation ix iliac limb to treat an iliac aneurysm.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately two (2) years post initial procedure, stent thrombosis that caused occlusion of the right afx limb of the bifurcated stent graft was identified.A open repair was completed with a non-endologix, bypass graft.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 # 2031527-2021-00248.This event per mfr.Report # 3008011247-2021-00041 is thus no longer reportable.
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.Report # 2031527-2021-00248.This event per mfr.Report # 3008011247-2021-00041 is thus no longer reportable.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11806931
• Report Number: 3008011247-2021-00041
• Device Sequence Number: 17224398
• Product Code: MIH
• UDI-Device Identifier: 00818009014740
• UDI-Public: (01)00818009014740(17)180721
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 07/21/2018
• Device Model Number: BEA25-60/I16-40
• Device Lot Number: 1723091-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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: OVATION IX FS090117-25
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR