MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA22-40/I13-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Occlusion (1984); Rupture (2208)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An afx2 bifurcated stent graft was used in combination with non-endologix devices in an off-label aiod case.After extended distally in both iliacs with uncovered self expanding stents, the patient's pressure dropped due to ruptured iliac.An balloon was inflated on the ipsi side and the physician repaired the rupture with a viabahn self expanding stent.At the completion of the case, the patient was reported as well.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the reported difficult to withdraw and right iliac rupture was determined to be user related, due to the off-label use of the device in a patient with aiod and the cautionary product use condition of the iliac anatomy.There was no device malfunction found, rather, there was evidence of a procedure-related right iliac artery rupture caused by ballooning of a contiguous non endologix stent in the distal common iliac artery (off-label use of concomitant products).Additionally, the right hypograstric artery was intentionally occluded, which is an additional procedure-related harm.The final patient disposition was reported as doing well.A review of the device quality records shows that the device demonstrated compliance to established procedure and specifications at the time of manufacture.(b)(4).

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6716354
• Report Number: 2031527-2017-00370
• Device Sequence Number: 831554
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)180512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2018
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 1686286005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/15/2017
• 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
• Patient Age: 66 YR