MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-100/I20-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a type 3a endoleak was identified.Patient is currently being monitored.This patient is part of a clinical study case.
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 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 concern for the type 3a endoleak is confirmed from the e-clinical documentation.This is 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 remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become device iteration is afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a type 3a endoleak was identified.Patient is currently being monitored.Note: this patient is part of a clinical study case.After the submission of the follow-up report, additional information was provided reporting that reintervention was performed.A gore (non-endologix) main body device was implanted in the infrarenal location uneventfully.The contralateral gate was then catheterized from the left groin access.The position was confirmed by spanning a flush catheter within the endograft.A stiff guidewire was placed through the catheter and then a marking catheter was placed to measure the length for contralateral limb extension.Angiogram was performed and the left hypogastric artery was marked.A 20mm bell bottom iliac limb extension was deployed uneventfully above the hypogastric artery.A similar set of steps was performed on the right side after completion of the main body graft deployment and removal of the endograft deployment system.A 20mm bell bottom iliac limb extension was deployed in the right iliac system landing above the hypogastric artery.All seal zones and overlap were ballooned with an aortic balloon.A completion aortogram was performed which revealed patency of the renal arteries bilaterally.Patency of both iliac limbs as well as hypogastric arteries and brisk flow into the external iliac arteries.There was no visualization of the prior visualized endoleak in the infrarenal abdominal aorta.The final patient status was not reported.
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 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 concern for the type 3a endoleak and additional endovascular procedure completed on (b)(6) 2021 is confirmed from the e-clinical documentation.This is 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 remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• 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: 12045021
• Report Number: 2031527-2021-00240
• Device Sequence Number: 4218154
• Product Code: MIH
• UDI-Device Identifier: 00818009014108
• UDI-Public: (01)00818009014108(17)190122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2021

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: 01/22/2019
• Device Model Number: BA25-100/I20-40
• Device Lot Number: 1435297-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 06/02/2022
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Male