MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Hematoma (1884); Failure of Implant (1924); Rupture (2208)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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.Device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure the patient presented emergently with abdominal pain and an enlarged aneurysm.Reportedly a computed tomography (ct) scan showed some contrast in the sac, but no signs of rupture.The physician elected to bring patient into the operating room and a pre-angiogram was done to try to identify a possible endoleak.However, no clear signs of a leak were identified.Out of an abundance of caution, the physician elected to re-line with another bifurcated stent graft and a proximal extension.Final angiogram showed great placement, and no signs of leak.Patient did very well.
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 review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 indeterminate endoleak and sac growth complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest an aortic rupture and right access site complication (hematoma) occurred that was not included in the event as reported.Procedure-related harms, device, user, procedure, or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported as being discharged to a skilled nursing facility on post operative day eight.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 received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure the patient presented emergently with abdominal pain and an enlarged aneurysm.The physician elected to bring patient into the operating room and a pre-angiogram was done to try to identify a possible endoleak.However, no clear signs of a leak were identified.Out of an abundance of caution, the physician elected to re-line with another bifurcated stent graft and a proximal extension.Final angiogram showed great placement, and no signs of leak.Patient did very well.Additional information: during the investigation there was evidence to reasonably suggest an aortic rupture and right access site complication (hematoma) occurred that was not included in the event as reported.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11896141
• Report Number: 2031527-2021-00219
• Device Sequence Number: 3400599
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/17/2021

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: 11/30/2018
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 1763579-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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: VELA SUPRARENAL, LOT# 1763582011; VELA SUPRARENAL, LOT# 1763582011
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR