MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	11/12/2021
Type of Reportable Event	Death
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 an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft an afx infrarenal extension, an express sd (non-endologix), and an endurant (non-endologix).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.Reportedly, due to the patient's short proximal neck the snorkel technique was used for this procedure.The express sd stent was deployed, then the endurant cuff was deployed on the proximal side via left access.The afx2 bifurcated stent graft was then deployed.Post deployment there was almost no overlap between the endurant cuff and the afx2 bifurcated stent graft.The afx infrarenal extension was deployed to bridge the two devices.Balloon touch up was performed; however, a residual type iiia endoleak remained.The physician elected to end the procedure and anticipated the type iiia endoleak would cease with medication (protamine).The patient was reported to continue to be monitored.(reported under mfr# 2031527-2022-00024).Approximately two (2) years post initial procedure the patient presented emergently due to aneurysm rupture.It was confirmed that the junction between the stent grafts had become loose.Reintervention was performed with implant of an afx vela infrarenal, an afx vela suprarenal, and two (2) gore (non-endologix) cuffs.The procedure was completed with a slight type iiia endoleak remaining.While being monitored in the hospital post-procedure patient condition suddenly changed although the endoleak was once confirmed to have been resolved.A junction separation was confirmed; however, the physician determined there was no room for further treatment.The patient expired.
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 was completed.An examination of medical records and/or medical imaging received by endologix shows the ruptured aorta, re-intervention, type iiia endoleak with component separation (between the bifurcated stent graft and multiple proximal stents) is confirmed from the still images.This is consistent with the reported adverse event/incident.The most likely causation for the rupture is the off-label use of concomitant products outside the ifu and the off-label neck anatomy.The most likely causation for the type iiia endoleak with component separation (bifurcated stent graft and four (4) proximal stents) is likely the burden on the bifurcated stent graft post-reintervention.The most likely causation for the death is likely aaa related.Procedure-related harms included was reported prolonged hospital stay followed by subsequent death.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.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: 13423908
• Report Number: 2031527-2022-00025
• Device Sequence Number: 3992451
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)201112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 11/12/2020
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 2010138003
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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 INFRARENAL EXTENSION (LN 2239246003); AFX VELA INFRARENAL (LN 2451756004 ); AFX VELA SUPRARENAL (LN 2335155001); ENDURANT (NON-ENDOLOGIX) CUFF (LN UNK); EXPRESS SD (NON-ENDOLOGIX) STENT (L UNK); GORE (NON-ENDOLOGIX) CUFF (LN UNK); GORE (NON-ENDOLOGIX) CUFF (LN UNK)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male