MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C80 V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the urgent presentation, type iiia endoleak, complete aortic component separation and secondary endovascular procedure.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was in stable condition post secondary endovascular procedure.A definitive root cause for the reported event could not be determined.The clinical assessment determined that there was evidence to reasonable suggest infra renal cuff dilation 40.9 mm (20%) occurred that were not included in the event as reported.The infra renal cuff dilation was discovered on (b)(6) 2018 during review of the 41 month post implant ct scan.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.The afx bifurcated stent graft indicated in describe event or problem and concomitant medical products, that had the endoleak 3a, was previously reported under mfr#2031527-2018-00220.
Event or Problem Description
An afx bifurcated stent graft system was implanted to treat an abdominal aortic aneurysm.The patient presented to the er with abdominal pain approximately 3.5 years post index procedure.A ct was performed on (b)(6) 2018, where a potential type iiia endoleak was observed.On (b)(6) 2018, the secondary procedure was performed.Reportedly, it was confirmed, there was no leak and no sac growth, just minimal overlap of the previously implanted stents.The physician elected to add a vela suprarenal cuff and a vela infrarenal cuff to improve overlap.The patient was discharged the next day and was reported to be pain free and in good condition.There have been no additional patient sequelae reported.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7655259
• Report Number: 2031527-2018-00570
• Device Sequence Number: 18871288
• Product Code: MIH
• UDI-Device Identifier: 00818009013545
• UDI-Public: (01)00818009013545(17)150502
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/02/2015
• Device Model Number: A34-34/C80 V
• Device Lot Number: 1249732020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 07/02/2018
• 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 BIFURCATED STENT GRAFT (LN 1268463027)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR