MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/06/2024
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 device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2015.Additionally, (3) three ovation ix iliac extenders were implanted on (b)(6) 2016 for an unknown reason.This procedure is outside the indications of use (off label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately nine (9) years post initial procedure, during a routine follow up, the left leg of the bifurcated stent graft was found to have separated from one of the ovation ix iliac extenders (classified as a type 3a endoleak).The physician elected to reline the previously implanted stent grafts with an additional afx2 bifurcated stent graft, an ovation ix iliac limb and an ovation ix iliac extender on (b)(6) 2024 to successfully resolve this event.The patient was reported as stable post-secondary procedure.
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 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 that the type 3a endoleak between the bifurcated stent graft and the left iliac limb and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely user related.There was concomitant product use of an ovation extension in the left common iliac artery.This likely caused the type 3a endoleak in the left common iliac artery.The clinical assessment determined that there was evidence to reasonably suggest type 1b 3ndoleak of the right common iliac artery occurred that was not included in the event as reported.The type 1b endoleak was discovered during review of the operative report dated 01/10/2024.The causation of the type ib endoleak in the right common iliac artery could not be determined.The clinical assessment could not determine further information on the additional endovascular procedure done 11/15/2016.The procedure related harm identified was a prolonged procedure.The final patient status was reported as discharge home on postoperative day one.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: g3: awareness date has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• 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: 18572936
• Report Number: 3011063223-2024-00008
• Device Sequence Number: 21122946
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)170723
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2024

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: 07/23/2017
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1264545014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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: OVATION IX ILIAC EXTENDER, LOT # FS042516-46; OVATION IX ILIAC EXTENDER, LOT # FS082916-20; OVATION IX ILIAC EXTENDER, LOT # FS090116-08
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male