MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-70/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Rupture (2208)
Date of Event	02/19/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a vela suprarenal stent graft extension, and a vela infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6.5 years post initial implant, a type 3 endoleak of unknown origin with sudden sac expansion and rupture occurred.It was reported that the patient expired.The cause of death was not provided.No further details were provided.
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 was able to confirm the reported sac growth of 19.1mm, rupture and indeterminate endoleak.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest endovascular procedures of coiling of type ii endoleaks of the lumbar arteries occurred.A type ii endoleak is a non- device related failure.Procedure related harms, device, user, procedure, or anatomy relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label due to the aorta neck angulation of 62 degrees should be equal to or greater than 60, however unclear if this contributed to the reported event.The final patient status was reported as being expired.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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a vela suprarenal stent graft extension, and a vela infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6.5 years post initial implant, a type 3 endoleak of unknown origin with sudden sac expansion and rupture occurred.It was reported that the patient expired.The cause of death was not provided.No further details were provided.Additional information: the clinical evaluation shows reasonable evidence to suggest endovascular procedures of coiling of type ii endoleaks of the lumbar arteries occurred.These findings were discovered during an examination of the angiogram studies.A type ii endoleak is a non device related failure.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11489394
• Report Number: 2031527-2021-00133
• Device Sequence Number: 16861399
• Product Code: MIH
• UDI-Device Identifier: 00818009010094
• UDI-Public: (01)00818009010094(17)170709
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 02/19/2021

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: 07/09/2017
• Device Model Number: BA22-70/I16-30
• Device Lot Number: 1264520010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL 1164321019; AFX VELA SUPRARENAL 1229347028; AFX VELA INFRARENAL 1164321019.; AFX VELA SUPRARENAL 1229347028.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR