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

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices involved in this event have been returned for evaluation which has not yet begun.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 1.5 years post initial procedure, the patient presented with aneurysm sac expansion (unknown diameter) during routine follow-up.The physician elected to treat the patient by explanting the devices about a month ago; as the exact explant date is unknown, the best estimate was used, which is the (b)(6) 2019.The patient reportedly tolerated the procedure well.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the returned devices was completed.A visual evaluation was performed.Based upon the analysis of the returned device, there is no evidence to suggest a quality problem/deficiency with respect to device manufacturing, design, or labeling.Endologix received two (2) afx bifurcated stent grafts, two (2) afx suprarenal stent graft and one (1) afx infrarenal stent graft for an evaluation.The afx bifurcated stent graft # 1 and both suprarenal stent grafts were in overall good condition.The graft material is in tack with no evidence of hole in the graft (type 3b endoleak).The stent cage shows no evidence of strut fracture or deformity.The afx bifurcated stent graft # 2 is in overall good condition.There is a small hole in the graft material (type 3b endoleak) at the bifurcation.The stent cage shows no evidence of strut fracture or deformity.Unable to determine if the hole was due to the explant procedure or present prior to being explanted.The afx infrarenal stent graft is in overall good condition.There is a large hole / tear in the graft material (type 3b endoleak) at the proximal end of the sent.The stent cage shows no evidence of strut fracture or deformity.Unable to determine if the hole was due to the explant procedure or present prior to being explanted.A clinical evaluation of the adverse event was completed.An examination of medical records and/or medical imaging received by endologix shows the devices were explanted and the sac growth was unconfirmed due to a lack of any medical imaging or relevant medical records.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was discharged on the seventh post operative day, reportedly doing fine.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: h6: device code: remove code 3190.H6: method code: remove code 4118.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 1.5 years post initial procedure, the patient presented with aneurysm sac expansion (unknown diameter) during routine follow-up.The physician elected to treat the patient by explanting the devices about a month ago; as the exact explant date is unknown, the best estimate was used, which is the (b)(6) 2019.The patient reportedly tolerated the procedure well.As of date, there have been no additional patient sequelae reported.Note; this patient has a secondary procedure for an unknown reason on (b)(6) 2017.An afx bifurcated stent graft and afx, vela suprarenal stent graft extension were implanted.This event was previously reported under 20131527-2018-00255.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8861783
• Report Number: 2031527-2019-00352
• Device Sequence Number: 11215562
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)171021
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 10/21/2017
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1283292-011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/28/2020
• 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: AFX BIFURCATED STENT GRAFT: 1111204-031; AFX INFRARENAL AORTIC EXTENSION: 1026652-016; AFX SUPRARENAL AORTIC EXTENSION: 1045631-044; AFX VELA SUPRARENAL: 1612817-005; BIFURCATED STENT GRAFT, LOT 1111204-031; INFRARENAL EXTENSION, LOT 1026652-016; SUPRARENAL EXTENSION, LOT 1045631-044; VELA SUPRARENAL, LOT 1612817-005
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR