MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Codes	Material Puncture/Hole (1504); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a 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 an afx vela infrarenal; this initial implant is outside the indications of use due to the absence of a bifurcated stent graft.Approximately one (1) year post initial procedure, the patient presented with a possible fabric tear (classified as a type iiib endoleak).The physician plans to re-intervene but surgery has not been scheduled.Patient is reportedly doing well.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx vela infrarenal; this initial implant is outside the indications of use due to the absence of a bifurcated stent graft.Approximately one (1) year post initial procedure, the patient presented with a possible fabric tear (classified as a type iiib endoleak).The physician plans to re-intervene but surgery has not been scheduled.Patient is reportedly doing well.Additional information received per clinical assessment indicating a secondary endovascular procedure was completed sometime between (b)(6) 2020 and (b)(6) 2021 where physician elected to treat the patient by implanting a non-endologix stent proximally near snorkels.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.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 reported type iiib endoleak of the proximal extension is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a secondary endovascular procedure occurred that was not included in the event as reported.This secondary procedure involved addition of a non-endologix stent sometime between (b)(6) 2020 and (b)(6) 2021.This finding was discovered during an examination of the ct (computed tomography) scan dated (b)(6) 2021.The most likely causation for the reported event is user-related due to concomitant product use of multiple stents and snorkels at the index procedure (off-label condition), and concomitant thoracic disease (cautionary product use conditon).Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was not reported.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: b2 outcomes attributed to ae.B5 describe event or problem.G4 awareness date.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11948041
• Report Number: 2031527-2021-00226
• Device Sequence Number: 1060299
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)221214
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/25/2021

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: 12/14/2022
• Device Model Number: A34-34/C100V
• Device Lot Number: 2316872-009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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-0008-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR