MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	10/28/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was initially treated for a ruptured abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an afx vela infrarenal.This initial procedure is contraindicative of the afx2 bifurcated stent graft indications for use as the safety and effectiveness of the system have not been evaluated for patients with ruptured aneurysms.Reportedly, at the index procedure, the patient had a very long renal to aortoiliac bifurcation.Due to the urgent nature of the case it is unknown if the correct size devices were available at the time.A complete seal was obtained at the initial procedure; however, the physician had to cover the left renal.The malposition of the graft occluded the left renal artery and resulted in post operative renal failure (device related), acute blood loss, respiratory failure, a left upper extremity deep vein thrombus, encephalopathy and additional surgical procedures (abdominal compartment syndrome).The final patient status was reported to be discharged to subacute rehabilitation on postoperative day fifteen.
Additional Manufacturer Narrative
The reported 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 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 the device remains implanted.A clinical evaluation of the incident was completed.An examination of medical records and/or medical imaging received by endologix shows the malposition of the afx2 bifurcated stent graft (covering left renal artery), left renal occlusion, postoperative renal failure, and additional surgical procedure (decompressive laparotomy) are confirmed.The event is most likely user and procedure related.The patient was initially treated for a ruptured abdominal aortic aneurysm (cautionary product use) which likely contributed to the reported event.The left renal artery was covered due to malposition of the afx2 endograft during emergent repair of the ruptured abdominal aortic aneurysm (procedure related), and this likely caused renal failure.The acute blood loss, respiratory failure, a left upper extremity deep vein thrombus, encephalopathy and an additional surgical procedure (abdominal compartment syndrome) were most likely due to the aortic rupture.No procedure related harms for this incident were identified.The final patient status was reported as discharged to subacute rehabilitation on postoperative day fifteen.No additional investigation of this reported 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 incidents.Device iteration is afx2.G3: awareness date ¿ updated 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: 16342147
• Report Number: 2031527-2023-00017
• Device Sequence Number: 6431069
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)180504
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/25/2023

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: 05/04/2018
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 1683479010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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 ((B)(6)); AFX VELA SUPRARENAL ((B)(6))
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male