MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I16-30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 3 (three) years later the patient presented for routine follow up and a type 3a was identified on a doppler us.Patient condition was reported as stable and a re-intervention has been scheduled.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 3 (three) years later the patient presented for routine follow up and a type 3a was identified on a doppler us.Patient condition was reported as stable and a re-intervention has been scheduled.Subsequent to the initial report, clinical assessment determined the type iiia endoleak included complete component separation which was not included in the event as reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type iiia endoleak (aortic) with complete component separation was confirmed.The secondary endovascular procedure is rescheduled for on (b)(6) 2020.Due to a lack of the relevant medical information (post implant ct study and/or operative notes, implant angiogram) the device, user, procedure or anatomy relatedness of this complaint could not be determined.The patient status was reported being stable.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.Corrections: b5: describe event or problem ¿ updated.H6: result code ¿ remove 3223.H6: conclusion code ¿ remove 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9935287
• Report Number: 2031527-2020-00131
• Device Sequence Number: 19516155
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)170621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 03/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2017
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 1484338003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT LN 1590772014); AFX VELA SUPRARENAL (LN 1252071008); AFX LIMB STENT GRAFT LN 1590772014); AFX VELA SUPRARENAL (LN 1252071008)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR