MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-100/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately six (6) and a half years post initial procedure, at routine follow-up a type ii endoleak (non-device related) from patent lumbers and inferior mesenteric artery was identified with suspect type iiib endoleak.Diagnostic angiogram is planned but has not been performed.The patient was reported to be asymptomatic.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.Device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately six (6) and a half years post initial procedure, at routine follow-up a type ii endoleak (non-device related) from patent lumbers and inferior mesenteric artery was identified with suspect type iiib endoleak.Diagnostic angiogram is planned but has not been performed.The patient was reported to be asymptomatic.Subsequent to the initial report, additional information was received reporting that angiogram was performed on (b)(6) 2022 and confirmed that there was only a type ii endoleak which was embolized.The afx bifurcated stent graft was intact with no issues.Patient is doing 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.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 type ii endoleak is confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the type ii endoleak is anatomy related.The procedure related harms for this complaint could not be determined.The contributing factor for the reported event is most likely the patent lumbar artery mentioned on (b)(6) 2015 operative notes.The final patient status was reported being stable post the embolization procedure.Type ii endoleaks are anatomy-related events and are not caused or contributed by the device.A complaint is not warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Therefore, this is no longer a reportable event.Device iteration is afx with duraply.B5: describe event or problem - updated.G4: awareness date ¿ updated.H6: patient code - removed 1708; 1924.H6: health effect - impact code - removed 4614.H6: medical device problem codes - removed 1504.H6: investigation finding codes - removed 3233.H6: investigation conclusion codes - removed 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• 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: 13660774
• Report Number: 2031527-2022-00040
• Device Sequence Number: 19309409
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)170820
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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: 08/20/2017
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1268475021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2014
• 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: AFX VELA SUPRARENAL (1329542007).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Male