MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C95 V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2020
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.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a vela infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a computed tomography (ct) identified a type 1a endoleak and graft migration.An intervention is being planned within the next six (6) months.Reportedly, the patient is fine.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a vela infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a computed tomography (ct) identified a type 1a endoleak and graft migration.An intervention is being planned within the next six (6) months.Reportedly, the patient is fine.Additional information: clinical review of computed tomography (ct) scan identified a type 2 endoleak (non-device related).
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was unable to find substantial evidence to support the reported event of the implant movement, and the implant migration with a type 1a endoleak based on the medical imaging available for review.Attempts were made to obtain medical records but was denied as patient authorization is needed.As such, procedure related harms device, user, procedure or anatomy relatedness of this event could not be determined with the medical imaging available to review.In addition, clinical review of the computed tomography (ct) scan identified a type 2 endoleak (non-device related).The final patient status was reported as being stable.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: b5: describe event or problem has been updated.D2: product description has been updated.D4: model number has been updated.D4: lot # has been updated.D4: expiration date has been updated.D4: unique identifier (udi) # has been updated.D11: concomitant medical products and therapy dates has been updated.H4: device manufacture date has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10114846
• Report Number: 2031527-2020-00161
• Device Sequence Number: 19653972
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)190106
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 11/20/2018
• Device Model Number: A25-25/C95 V
• Device Lot Number: 1428397005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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: BIFURCATED STENT GRAFT, LOT NO. 1291688008; VELA INFRARENAL, LOT# 1428397005; VELA INFRARENAL, LOT# 1428397005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR