MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent grafts, two (2) vela suprarenal, and a vela infrarenal to treat an abdominal aortic aneurysm (aaa).Approximately one (1) month post initial implant, the patient was identified with a possible type 3a endoleak.At the reintervention it was determined that there was a type ii endoleak (non-device related) and not a type 3a endoleak.The type ii endoleak was relined with an afx2 bifurcated stent graft, and two (2) afx vela suprarenal; however, the type ii endoleak was still present at the end of the procedure.(possible type 3a endoleak reported under mfr# 2031527-2021-00313).Approximately two and a half (2.5) months post-reintervention, left limb occlusion was identified.The issue appears to be critical stenosis at the proximal external iliac (junction of the internal).Successful reintervention was completed opening the left common iliac artery.Endarterectomy was performed first, crossed the critical stenosis on the external iliac, ballooned the stenosis with an 8x4 pta balloon, then deployed the afx limb stent graft across the clot that formed through the limb.The patient is doing well.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
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 remains implanted.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being doing well.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.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• 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: 12888053
• Report Number: 2031527-2021-00473
• Device Sequence Number: 19192800
• Product Code: MIH
• UDI-Device Identifier: 00818009014467
• UDI-Public: (01)00818009014467(17)240218
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 02/18/2024
• Device Model Number: BEA28-80/I16-40
• Device Lot Number: 2427303-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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 VELA INFRARENAL(LN 2368133-010).; AFX VELA SUPRARENAL (LN 2333628-006).; AFX VELA SUPRARENAL (LN 2376902-010).; AFX VELA SUPRARENAL (LN 2380233-002).; AFX VELA SUPRARENAL (LN 2380233-003).; AFX2 BIFURCATED STENT GRAFT (LN 2431887-004).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female