MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Failure of Implant (1924); Rupture (2208)
Date of Event	06/20/2022
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 implanted with a bifurcated stent graft and a suprarenal extension to treat an abdominal aortic aneurysm (aaa).Approximately two and a half (2.5) months post-initial procedure, the patient was admitted to an unknown hospital due to a fever and abdominal pain.Around one (1) month post-admission, the patient was transferred to the hospital where the index procedure had been performed (the exact date is unknown).On (b)(6) 2022, the patient complained of abdominal pain.A computerized tomography was done and identified an aortic rupture around the proximal neck (non-aneurysm rupture).There was no endoleak observed.Reportedly, the bifurcated stent graft and suprarenal extension morphology had changed since the initial implant, and the patient has been taking steroids for an unknown reason.On (b)(6) 2022, reintervention was completed with the implant of three (3) gore (non-endologix) excluders and one (1) gore (non-endologix) c-tag.The patient¿s status post-reintervention is unknown.
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.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 aortic proximal neck rupture was confirmed.The additional endovascular procedure, aortoduodenal fistula, and open repair were unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 1a endoleak and sac growth also occurred.This was discovered during a review of the computed tomography (ct) scan on (b)(6) margin of the infrarenal proximal extension landed in the sharp 86-degree angulation.The superior stent margin of the infrarenal proximal extension was in a suboptimal position at 39mm b(6)elow the left renal artery.It is unclear if there was any migration of the proximal extension or if it was placed there at the index.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 as being in stable condition after the open repair.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.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal extension to treat an abdominal aortic aneurysm (aaa).Approximately two and a half (2.5) months post-initial procedure, the patient was admitted to an unknown hospital due to a fever and abdominal pain.Around one (1) month post-admission, the patient was transferred to the hospital where the index procedure had been performed (the exact date is unknown).On (b)(6) 2022, the patient complained of abdominal pain.A computerized tomography was done and identified an aortic rupture around the proximal neck (non-aneurysm rupture).There was no endoleak observed.Reportedly, the bifurcated stent graft and suprarenal extension morphology had changed since the initial implant, and the patient has been taking steroids for an unknown reason.On (b)(6) 2022, reintervention was completed with the implant of three (3) gore (non-endologix) excluders and one (1) gore (non-endologix) c-tag.The patient¿s status post-reintervention is unknown.Additional information was provided reporting that the patient visited a different hospital (gunma university hospital) for aorto-duodenal fistula treatment (the exact date is unknown).The patient was admitted to that hospital right away and had the open surgery on (b)(6) 2022.The stent grafts were removed and replaced with a blood vessel prosthesis.A fistula repair was also performed.The patient¿s post-operative status was stable.According to the physician, the cause of fistula was due to the duodenum compression caused by hematoma after the rupture on (b)(6) 2022.
Additional Manufacturer Narrative
Correction: b5: describe event or problem - additional information.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 15017620
• Report Number: 2031527-2022-00184
• Device Sequence Number: 6857238
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)240407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2022

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: 04/07/2024
• Device Model Number: A34-34/C100V
• Device Lot Number: 2448983008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/12/2022; Not provided
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/20/2022; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX2 BIFURCATED STENT GRAFT (LN 2516421008)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male