MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95 O20V
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/16/2019
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.¿device iteration is afx with duraply¿.Device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately, 7 months post implant during a routine follow up, a type iiib endoleak was identified.Physician elected to implant another bifurcated stent graft to treat this event.The patient is doing well.
Additional Manufacturer Narrative
The manufacturing lot review confirmed all devices met specifications prior to release.The devices were not returned as they remain implanted, and therefore no sample evaluation was completed.A clinical assessment was completed based on the received medical records.The reported type iiib endoleak of the proximal extension was confirmed.This event is most likely anatomy-related due to the thickened calcifications at the site of the endoleak.The procedure-related harms for the event could not be determined, and the final patient status was reportedly well post reline procedure.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.Corrections to h6 result code; remove 3233 h6 conclusion code; remove 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately, 6 months post implant during a routine follow up a type iiib endoleak was identified.Physician elected to treat with another bifurcated stent graft.Patient is reportedly doing well.As of date, there have been no additional patient sequelae reported.Additional information received confirming that the type iiib endoleak was successfully resolved at the conclusion of the re-intervention on (b)(6) 2019.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9594244
• Report Number: 2031527-2020-00014
• Device Sequence Number: 16258100
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)211026
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 08/04/2020
• Device Model Number: A25-25/C95 O20V
• Device Lot Number: 1726632-002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT, SERIAL # (B)(6).; INFRARENAL EXTENSION, LOT#1726632002
• Outcome Attributed to Adverse Event: Required Intervention