MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/09/2020
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.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 an afx bifurcated stent graft, and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3a endoleak was identified.The physician elected to treat this event by re-lining the existing stent grafts with a non-endologix (31mm gore tag) device.This procedure is outside the indications of use due to concomitant use with products outside the ifu.This event was reported under mdr# 2031527-2019-00250.Now, approximately one and a half (1.5) years post secondary intervention, an indeterminate endoleak was identified.The patient is being monitored pending re-intervention.
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.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 indeterminate endoleak is a type 3a endoleak between the non endologix and endologix proximal extensions.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth.The most likely causation for the type 3a endoleak is the concomitant product use of a non endologix proximal extension (off ifu).The final patient status was reported as stable post the secondary procedure.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.Corrections: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.D4: model number has been updated.D4: lot # has been updated.D4: expiration date has been updated.D4: unique identifier (udi) # has been updated.D11: concomitant medical products and therapy dates has been updated.G1/g2: contact office - name has been updated.G4: date received by manufacturer has been updated.H4: device manufacture date 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 an afx bifurcated stent graft, and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3a endoleak was identified.The physician elected to treat this event by re-lining the existing stent grafts with a non-endologix (31mm gore tag) device.This procedure is outside the indications of use due to concomitant use with products outside the ifu.This event was reported under mdr# 2031527-2019-00250.Now, approximately one and a half (1.5) years post secondary intervention, an indeterminate endoleak was identified.The patient is being monitored pending re-intervention additional information: the reported indeterminate endoleak was identified to be a type 3a endoleak between the non endologix and endologix proximal extension.Clinical evaluation shows reasonable evidence to suggest sac growth.A secondary procedure was completed.The physician elected to implant a suprarenal aortic extension and an ovation ix iliac extender to resolve this event.The patient was reported as being stable post secondary procedure.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10953795
• Report Number: 2031527-2020-00360
• Device Sequence Number: 2419185
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)180129
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/09/2020

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: 04/01/2018
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1329542015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 04/05/2021
• 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-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT # 1313205003; NON-ENDOLOGIX (GORE TAG) DEVICE; NON-ENDOLOGIX (GORE TAG) DEVICE; VELA SUPRARENAL, LOT# 1329542015
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR