MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-40/I13-40
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Thrombus (2101)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
Patient initially implanted with an afx2 bifurcated and ovation limb on (b)(6) 2018.Approximately two weeks post implant, patient presented with claudication, a duplex showed narrowing in the left limb of the afx2.Patient was brought in on (b)(6) 2018 for interventions, which was when the physician discovered that the patient had a complete occluded left limb with thrombus and a 50% stenosis in the right ovation iliac limb (reported in a separate report).The physician elected to intervened with angiojet and placed two non-endologix stents in both iliac limbs of the previously placed afx graft.The issues were resolved.The patient was discharged home.
Additional Manufacturer Narrative
At the completion of the investigation, the reported total occlusion of the left common iliac artery and partial right common artery stenosis (report # 3008011247-2018-00112) complaint is confirmed.The complaint is most likely anatomy related (aorto-iliac occlusive disease) and is outside of treatment range.Procedure related harms for this complaint included re-occlusion of left iliac stent and a secondary endovascular procedure on (b)(6) 2018.The final patient status was reported to be stable discharged home.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7545031
• Report Number: 2031527-2018-00486
• Device Sequence Number: 1169687
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)190222
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: Physician
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 1811838009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: OVATION ILIAC LIMB-LOT: FS072417-70; OVATION ILIAC LIMB-LOT: FS072417-70
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR