MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I16-40
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Failure of Implant (1924); Renal Failure (2041); Respiratory Failure (2484)
Date of Event	07/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been received and is pending evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
During deployment of an afx2 bifurcated stent graft, the rip cord did not come out after the graft had opened normally.Upon attempting to remove the nosecone, the physician could not get it past the bifurcation.The patient was converted to open surgery.In the explanted graft, the release cord was found to be looped around the main body just above the bifurcation.Patient is reported as not doing well and is still intubated with respiratory issues.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the inability to pull back the control cord, retract the outer cover, and retract the nose cone was found to be unknown/undetermined due to the lack of medical records and imaging surrounding the event.Procedure-related harms, and the final patient disposition could not be ascertained as well.The patient was reported to be doing poorly with renal and respiratory complications.To date, there has been no reports of further negative patient sequelae.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6817293
• Report Number: 2031527-2017-00397
• Device Sequence Number: 10788421
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)180512
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

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: No Information
• Device Expiration Date: 05/12/2018
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 1686160-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention