MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Codes	Off-Label Use (1494); Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, two (2) vela suprarenal stent grafts and a limb stent graft to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial implant during a routine follow up, the patient was identified with a type 3a endoleak with component separation.The physician elected to implant another suprarenal stent graft and an infrarenal stent graft to treat this event.The patient was reported as stable post re-intervention.This event was previously reported under mdr # 2031527-2021-00056.Approximately three (3) months post re-intervention, an unknown proximal endoleak, an unknown distal type 3 endoleak (type unknown) and aneurysm sac growth were identified.No further information was provided, and the patient status was not reported.
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 afx2.
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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the indeterminate endoleak and sac growth of 11.3mm complaints are confirmed.This is consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the lack of medical records and/or imaging available for review.Additionally, the clinical evaluation also shows that there was evidence to reasonably suggest stent movement of a proximal extension of 8mm occurred that was not included in the event as reported and there was a non endologix limb placed in the right external iliac artery.It is unclear if this contributed to the reported event.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: b5: describe event or problem -updated.D1: brand name has been updated.D2: product description has been updated.D4: model number has been updated.D4: catalog number has been updated.D4: lot # has been updated.D4: expiration date has been updated.D4: unique identifier (udi) # has been updated.D10: therapy dates has been updated.G3: date received by manufacturer - updated.H4: device manufacture date has been updated.H6: medical device problem codes: remove code 3190.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, two (2) vela suprarenal stent grafts and a limb stent graft to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial implant during a routine follow up, the patient was identified with a type 3a endoleak with component separation.The physician elected to implant another suprarenal stent graft and an infrarenal stent graft to treat this event.The patient was reported as stable post re-intervention.This event was previously reported under mdr # 2031527-2021-00056.Approximately three (3) months post re-intervention, an unknown proximal endoleak, an unknown distal type 3 endoleak (type unknown) and aneurysm sac growth were identified.No further information was provided, and the patient status was not reported.Additional information: clinical evaluation shows that a non endologix limb was placed in the right external iliac artery.Clinical evaluation also shows at there was evidence to reasonably suggest stent movement of a proximal extension of 8mm occurred that was not included in the event as reported.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• 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: 13256124
• Report Number: 2031527-2022-00008
• Device Sequence Number: 11910698
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)170621
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 08/30/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1581298-008
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT#1354740-009.; LIMB STENT GRAFT, LOT # 1361096002.; LIMB STENT GRAFT, LOT#1361096002.; VELA INFRARENAL, LOT # 2410264013.; VELA INFRARENAL, LOT#2410264013.; VELA SUPRARENAL, LOT # 1581298008.; VELA SUPRARENAL, LOT # 1581298009.; VELA SUPRARENAL, LOT # 2393926007.; VELA SUPRARENAL, LOT#1581298009.; VELA SUPRARENAL, LOT#2393926007.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male