MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I20-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm (1708); Pain (1994)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event have not been returned for evaluation and endologix continues to follow-up with the physician regarding the status of the explanted device.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented to the emergence room with an evident endoleak by ct scan that the physician defined as endotension or type ii endoleak.The patient is stable but is complaining of abdominal pain.The physician elected to treat the patient by explanting the afx graft on (b)(6) 2018.In addition, the physician noted there was murky fluid around the graft prior to explant, and the culture results are pending.The patient is sick post-operatively but stable.Endologix continues to follow-up with the physician regarding the status of the explanted device.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of an indeterminate endoleak (type ii versus type v).In addition, there was reported to be murky fluid around the graft; two blood cultures (anaerobic) were positive, but without the discharge summary (requested and not received) it cannot be determined if the septicemia came from the aortic sac.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure-related harms for this complaint could not be determined.The final patient status was reported to be stable post open repair.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: patient code - remove 1685.Method code - remove 4118.Result code - remove 3233.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7748518
• Report Number: 2031527-2018-00637
• Device Sequence Number: 1319725
• Product Code: MIH
• UDI-Device Identifier: 00818009012227
• UDI-Public: (01)00818009012227(17)180608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: 06/08/2018
• Device Model Number: BA25-90/I20-30
• Device Lot Number: 1251838-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA SUPRARENAL-LOT 1252430-021; AFX-VELA SUPRARENAL-LOT 1252430-021
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR