MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Codes	Material Puncture/Hole (1504); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/27/2020
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 implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3b endoleak, a type ia endoleak and movement of the afx vela suprarenal were identified during routine follow-up.Due to the hostile neck anatomy the physician elected to explant the device.The final patient status was to be recovering well.The final patient status was reported to be 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 review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the returned device was completed.Endologix received a one (1) afx2 bifurcated stent graft, bea28-100/i16-40 and one (1) vela suprarenal stent graft, a34-34/c100-o20 v for evaluation.A visual analysis was performed.The afx2 bifurcated stent graft, bea28-90/i20-30 was visual inspected.The integrity of the graft appears to be intact with no visible defects.The vela suprarenal stent graft, a34-34/c100-o20 was visual inspected.The stent graft has a hole approximately 10 mm in length.The hole is located at the proximal end of the stent and is consistent with a type 3b endoleak.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the type 3b endoleak of the suprarenal stent graft and explant were confirmed however the reported type 1a endoleak with implant movement were unable to be confirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported being stable.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.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10885439
• Report Number: 2031527-2020-00347
• Device Sequence Number: 19585043
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)170202
• 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: 2016
• Device Explanted Year: 2020
• 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): 10/27/2020

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: 05/18/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1472880-022
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN 1472880022); BIFURCATED STENT GRAFT, LOT 1356560009; AFX VELA SUPRARENAL (LN 1472880022)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR