MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/15/2019
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.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 the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial implant during a routine follow-up cta scan the patient was found to aneurysm sac enlargement of one (1) centimeter.There is no evidence of an active leak occurring and a follow-up ct scan will be performed at a later date.The patient is stated as being in good condition.No further additional information or patient sequelae has been reported at this time.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial implant during a routine follow-up cta scan the patient was found to aneurysm sac enlargement of one (1) centimeter.There is no evidence of an active leak occurring and a follow-up ct scan will be performed at a later date.The patient is stated as being in good condition.No further additional information or patient sequelae has been reported at this time.Additionally, clinical assessment determined that there was evidence to reasonably suggest a type iiib endoleak of the cuff occurred that was not included in the event as reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported sac growth was unconfirmed; however, it was determined that there was evidence to reasonably suggest a type iiib endoleak of the proximal extension (vela suprarenal).Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted; therefore, no 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 afx with duraply.Corrections: a2: date of birth ¿ updated b1: adverse event or product problem ¿ updated b5: describe event or problem ¿ updated d2: product description ¿ updated d4: model #/lot #/expiration date/udi# - updated g1,2: contact office- name has been updated h4: manufacturing date ¿ updated h6: patient code ¿ remove 1708 h6: device code - remove 3190 h6: result code ¿ remove 3233 h6: conclusion code ¿ remove 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8687338
• Report Number: 2031527-2019-00272
• Device Sequence Number: 14040645
• Product Code: MIH
• UDI-Device Identifier: 00818009010100
• UDI-Public: (01)00818009010100(17)180810
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 06/12/2018
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1352627011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 05/18/2020
• 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-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT; VELA SUPRARENAL (LN 1352627-011); VELA SUPRARENAL (LN 1352627-011)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR