MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	06/19/2021
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 treated for an abdominal aortic aneurysm (aaa) with a bifurcated device and two suprarenal aortic extensions.Approximately (1) one-month post initial procedure, a 1a endoleak was identified during a routine follow-up.A re-intervention was done, and the physician elected to implant an afx vela suprarenal (mfr# 2031527-2015-00208).Now approximately (6) six years post-re-intervention the patient was presented to the emergency room (e/r) due to an endoleak type 3a and aorta rupture.A re-intervention was done and the physician implanted a (non-endologix) gore excluder graft.The final patient status was reported as 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.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 rupture and additional endovascular repair is confirmed.The type 3a endoleak is unconfirmed.This is moderately consistent with the reported adverse event/incident.The device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The procedure/rupture related harms identified were acute kidney injury, hypotension, abnormal blood loss.The final patient status was discharged on the fourth post operative day in good condition.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: g4 awareness date h6 evaluation result codes; remove 3233 h6 evaluation conclusion codes; remove 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12168133
• Report Number: 2031527-2021-00268
• Device Sequence Number: 14602512
• Product Code: MIH
• UDI-Device Identifier: 00818009014160
• UDI-Public: (01)00818009014160(17)180119
• 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: 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): 06/26/2021

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: 01/19/2018
• Device Model Number: BA28-110/I16-30
• Device Lot Number: 1312134014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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 SUPRARENAL 1252069020; AFX VELA SUPRARENAL 1252471002; AFX VELA SUPRARENAL 1252473024; AFX VELA SUPRARENAL 1252069020; AFX VELA SUPRARENAL 1252471002; AFX VELA SUPRARENAL 1252473024
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR