MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Rupture (2208)
Date of Event	01/14/2021
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.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, a vela infrarenal stent graft, and an ovation ix extender to treat an abdominal aortic aneurysm (aaa).This 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 one (1) year post initial implant, the patient presented emergently with back and abdominal pain.A computed axial tomography (cat) scan identified a ruptured aneurysm and subsequent angiogram revealed type 1b and type 3b endoleaks.The physician completed a successful re-intervention with the implant of an afx2 bifurcated stent graft, and a non-endologix (gore vbx) iliac stent to resolve the endoleaks.The patient reportedly is doing well post re-intervention.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a vela infrarenal stent graft, and an ovation ix extender to treat an abdominal aortic aneurysm (aaa).This 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 one (1) year post initial implant, the patient presented emergently with back and abdominal pain.A computed axial tomography (cat) scan identified a ruptured aneurysm and subsequent angiogram revealed type 1b and type 3b endoleaks.The physician completed a successful re-intervention with the implant of an afx2 bifurcated stent graft, and a non-endologix (gore vbx) iliac stent to resolve the endoleaks.The patient reportedly is doing well post re-intervention.Additional information: the rupture complaint is refuted, rather both the operative note and discharge summary stated no evidence of rupture.
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.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 rupture event/incident was refuted, the type 1b endoleak of the right common iliac artery was confirmed, but the type 3b endoleak was unconfirmed.This is moderately consistent with the reported adverse events/incidents.The most likely causation for these events were user related due to the following off-label use.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The patient had previous open repair procedures in 1994 and 2006.Placing an afx stent graft and proximal extension in an open repair graft is outside of the treatment range.The index procedure on 11dec/2019 was done to repair a pseudoaneurysm at the anastamatosis of the dacron (non- endologix) graft and the native aortic stump (off label implant condition).It was unclear if the use of an ovation extender in the left common iliac artery contributed to the reported event.Whereas the type iiib endoleak was unconfirmed, placing a main body graft in a dacron surgical graft is off label and could have contributed to the reported event.The final patient status was reported as doing well post re-intervention.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.Corrections: g4: date of received by manufacturer.H6: patient code: remove code 2208.H6: device code: remove code 3190.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11294594
• Report Number: 2031527-2021-00041
• Device Sequence Number: 19794808
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)200717
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2020
• Device Model Number: BEA28-70/I20-30
• Device Lot Number: 1721675008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: OVATION IX EXTENDER, LOT FS022418-67; VELA INFRARENAL, LOT 2025093002; OVATION IX EXTENDER, LOT FS022418-67; VELA INFRARENAL, LOT 2025093002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR