MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	10/17/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this 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 a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3b endoleak with sac growth was identified while the patient was being treated for a bowel obstruction.The patient was reported as stable and an intervention has been scheduled.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3b endoleak with sac growth was identified while the patient was being treated for a bowel obstruction.The patient was reported as stable and an intervention has been scheduled.Subsequent to the initial report, additional information was received that the patient due to complications from her small bowel instruction surgery.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.Several requests were made for medical imaging; however, no response was received.The reported type iiib endoleak with sac growth was unconfirmed due to the lack of relevant medical imaging.The reported patient death was confirmed from the discharge summary received.The patents death was most likely anatomy related (small bowel obstruction not related to the evar procedure).Post resection of the small bowel obstruction there was the sequelae of hypotension, respiratory failure during a dialysis procedure.No procedure harms were identified.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.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: b2: outcomes attributed to adverse vent - updated; b5: describe event or problem ¿ updated; h1: type of reportable event - updated; h6: result code ¿ remove 3221; h6: conclusion code ¿ remove 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9329097
• Report Number: 2031527-2019-00510
• Device Sequence Number: 11417228
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)171212
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 12/12/2017
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1252327-022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 11/17/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 06/11/2020
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT 1333222-017.; VELA SUPRARENAL, LOT 1333222-017
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Age: 83 YR