MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, during a routine follow-up, a type 3a endoleak and aneurysm enlargement of 1cm was identified.The physician plans to do a reline.
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 h3 other text: device remains implanted.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, during a routine follow-up, a type 3a endoleak and aneurysm enlargement of 1cm was identified.The physician plans to do a reline.Additional information: a comprehensive clinical assessment has yielded substantial evidence pointing toward the presence of a type iiib endoleak within the distal main body.The identification of this endoleak occurred on july 17, 2023, as part of a meticulous review of a computerized tomography (ct) scan dated on (b)(6) 2023.Following an angiogram, a comprehensive examination was conducted on the patient, which did not yield any evidence of the presence of the leak.As a result, it has been determined that a re-intervention will not be necessary at this time.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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 afx2 type iiia endoleak and aneurysm enlargement are unconfirmed.This is not consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type iiib endoleak of the distal main body occurred.The type iiib endoleak was discovered on july 17, 2023, during a review of the computerized tomography (ct) scan dated on (b)(6) 2023.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.No contributing factors were identified.The final patient status is reported as doing fine, pending reintervention.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.Corrections: b3: date of event updated.B5: describe event or problem updated.G3: awareness date has been updated.H6: investigation medical device problem codes: remove code 4065.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: AFX2
• 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: 16992491
• Report Number: 2031527-2023-00164
• Device Sequence Number: 6814640
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: 09/14/2020
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 1739882-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL 2276385012.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male