MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Death (1802); Pain (1994)
Date of Event	12/02/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remained 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, a suprarenal stent graft extension and a limb stent graft extension to treat an abdominal aortic aneurysm.Approximately four (4) years post initial procedure, patient presented emergently with back and belly pain and a type 1b endoleak from the left common iliac was detected.Reportedly, during re-intervention patient coded before gaining access, but was recesitated.Physician then placed 2 ovation limb extensions and after placement of the stents an angiogram was performed and the leak was still present.Physician determined that the patient had a type 3b endoleak and while the physician was preparing to reline the graft the patient coded a second time and expired.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The patient death complaint is unconfirmed due to a lack of relevant medical records.The type iiib of the main body and type ib endoleak of the right common iliac complaints are confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.No contributing factors 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: result code: remove code remove code 3233.Conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9535954
• Report Number: 2031527-2019-00633
• Device Sequence Number: 3389547
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)171014
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1283284014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 04/30/2020
• 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: LIMB STENT GRAFT, LOT# 1252606027; VELA SUPRARENAL, LOT# 1252485039; LIMB STENT GRAFT, LOT# 1252606027; VELA SUPRARENAL, LOT# 1252485039
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR