MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-90/I16-30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Separation Problem (4043)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event were explanted but will not be returned for evaluation as they were disposed of at the hospital.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 an afx bifurcated stent graft and an afx infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years later, the patient presented symptomatic where an examination revealed a type 3a endoleak with complete separation of the afx bifurcated stent graft and the infrarenal stent graft extension.The physician performed an open conversion surgery, explanted the devices, and treated the patient with a non-endologix aortic graft.The surgery was successful and the patient was reportedly in stable condition.The explanted devices were both disposed of at the hospital.
Additional Manufacturer Narrative
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it was discarded.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 surgical conversion event was unconfirmed.The type iiia endoleak of the aortic components were confirmed.The likely causation of the reported event was the significant angulation of the mid aorta (approximately 60 degrees) which is anatomy related, and this most likely contributed to the type iiia endoleak.Clinical investigation was unable to measure exact angulation from still photos provided.Procedure related harms could not be determined.The final patient status remains unknown and 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.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10488792
• Report Number: 2031527-2020-00248
• Device Sequence Number: 17167177
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)190406
• Combination Product (Y/N): N
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2019
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1423843003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX INFRARENAL EXTENSION, LOT NO. 1379607024; AFX INFRARENAL EXTENSION, LOT NO. 1379607024
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR