MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
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 is refuted, rather there is a type 3b endoleak of the bifurcated stent graft.This is not 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 was not reported.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.Device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and two (2) infrarenal aortic extensions to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, during routine follow-up there was an observed increase of the aneurysm sac (12.1mm to 16.9mm) in the common iliac artery and a type 3a endoleak was suspected.The patient is currently being monitored while an intervention is being discussed.Additional information received per clinical assessment refuting the reported 3a endoleak, and rather confirming a 3b endoleak was present.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12288853
• Report Number: 2031527-2021-00295
• Device Sequence Number: 14576509
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)191212
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 12/12/2019
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1624880014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/06/2021
• 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: INFRARENAL AORTIC EXTENSION, LOT # 1379610014; INFRARENAL AORTIC EXTENSION, LOT # 1621884007
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR