MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-70/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2022
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately 6 years post initial procedure patient was identified with a type iiib endoleak and the physician elected to perform an explant.Reportedly, during repair it was found that the patient was also implanted with an afx infrarenal extension at some point between post initial procedure and the explant; this event will be reported under a separate medical device report.
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.Endologix received a one (1) afx bifurcated stent graft, one (1) infrarenal stent graft and one (1) suprarenal stent graft for evaluation.The devices were shipped in a biohazard bag within a box.Blood and tissue residue were present upon receipt.The devices were decontaminated.A visual analysis was performed.The afx bifurcated stent graft was visually inspected.There was small hole in the stent graft near the bifurcation and one of the stent struts appeared to be pushing through the graft.The infrarenal stent graft and suprarenal stent graft were visually inspected.The integrity of the graft appeared to be intact with no visible defects.The reported type 3b endoleak was confirmed as a hole in the graft was identified.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix was unable to confirm the reported type 3b endoleak with open repair/ explant.However, the reported type 3b endoleak and explant of the devices were confirmed during the device evaluation as there was a hole in the graft identified.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 or with the evaluation of the devices.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 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.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately 6 years post initial procedure patient was identified with a type iiib endoleak and the physician elected to perform an explant.Reportedly, during repair it was found that the patient was also implanted with an afx infrarenal extension at some point between post initial procedure and the explant; this event will be reported under a separate medical device report.Clarification: the patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately 6 years post initial procedure patient was identified with a type 3b endoleak and the physician elected to perform an open repair.The endologix devices were explanted and replaced with an aortic graft.Reportedly, the patient was also implanted with an afx infrarenal extension at some point between post initial procedure and this open repair / explant; this event was reported under a separate medical device report 2031527-2022-00045.

• 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: 13667084
• Report Number: 2031527-2022-00041
• Device Sequence Number: 5303185
• Product Code: MIH
• UDI-Device Identifier: 00818009010094
• UDI-Public: (01)00818009010094(17)181117
• 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: 2016
• 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: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 11/17/2018
• Device Model Number: BA22-70/I16-30
• Device Lot Number: 1297631014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2015
• 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 INFRARENAL EXTENSION, LOT UNKNOWN; SUPRARENAL AORTIC EXTENSION, LOT#1389168020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male