MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

Device Problem Collapse (1099)

Patient Problems Occlusion (1984); Thrombosis (2100); Stenosis (2263); Claudication (2550)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was initially treated with the afx2 abdominal aortic aneurysm stent; a "thrombrosed" right limb and twisted bifurcation were noted at implant.Approximately four (4) months post initial procedure, an occluded right limb and twisted distal portion of the bifurcation was detected with claudication of the right leg.The physician plans to re-intervene and will continue to monitor the patient.There have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: suboptimal placement of the implant (slightly twisted anterior-posterior limbs) with good outflow at implant (but later, ischemic right leg), and right iliac 100% stent buckling with occlusion.This event was most likely user related.The clinical assessment determined that there was also evidence to reasonably suggest: critical stenosis of the left aorto-iliac junction due to near complete stent buckling of the bifurcated stent.This event is most likely user related as well due to the suboptimal position of the bifurcated stent at implant (a-p orientation as opposed to transverse).This finding was discovered during the review of the five month post implant ct scan.Procedure related harms included a type ii endoleak.The final patient status was reported to be experiencing right sided claudication.The manufacturing lot review 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.

Event Description

Additional information received per clinical assessment confirming that stenosis of the left aorto-iliac junction and a type ii endoleak were also present at the time of the reported event.

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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the suboptimal placement of the implant was confirmed (slightly twisted anterior-posterior limbs) with good outflow at implant (but later, ischemic right leg) right iliac 100% stent buckling and occlusion was confirmed.This is consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonable suggest critical stenosis of the left aorto-iliac junction due to near complete stent buckling of the bifurcated stent.This event is most likely user related as well due to the suboptimal position of the bifurcated stent at implant.This finding was discovered on (b)(6) 2018, during the review of the five month post implant ct scan.User-related: suboptimal placement of the bifurcated stent upon the natural bifurcation (a-p orientation as opposed to transverse).This event was most likely user related.Procedure related harms included a type 2 endoleak.The final patient status was reported to be experiencing right sided claudication.Additionally, a femoral to femoral bypass procedure was performed; however, it is unconfirmed based on the clinical assessment.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.Device iteration is afx2.Corrections: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G1: contact office - name has been updated.G2: report source has been updated.G3: awareness date has been updated.H6: investigation finding code: remove code 3221.H6: investigation conclusion codes: remove codes 22, 61.

Event Description

The patient was initially treated with the afx2 abdominal aortic aneurysm stent; a thrombrosed right limb and twisted bifurcation were noted at implant.Approximately four (4) months post initial procedure, an occluded right limb and twisted distal portion of the bifurcation was detected with claudication of the right leg.The physician plans to re-intervene and will continue to monitor the patient.There have been no additional patient sequelae reported.Additional information received per clinical assessment confirming that stenosis of the left aorto-iliac junction and a type ii endoleak were also present at the time of the reported event.Additional information was received stating a femoral to femoral bypass was performed in (b)(6) 2019.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8056809
• MDR Text Key: 126717848
• Report Number: 2031527-2018-00846
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)181129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2018
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 1763294-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/28/2018; Not provided
• Supplement Dates FDA Received: 01/03/2019; 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX-VELA SUPRARENAL: (B)(4); AFX-VELA SUPRARENAL: (B)(4)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR