MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Separation Problem (4043)

Patient Problem Myocardial Infarction (1969)

Event Date 10/03/2023

Event Type  Injury  

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 afx2.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa).The afx2 bifurcated stent graft was successfully deployed without issue.Difficulty removing the afx2 bifurcated stent graft delivery system post-deployment was experienced.Due to the resistance, the physician felt that the delivery system was pulling on the graft and as though the graft was still connected to the delivery system.In attempt to remove the delivery system the inner core was turned 90 degrees which was unsuccessful; the inner core was moved back and forth while trying to remove the delivery system and was unsuccessful; a lunderquist wire (non-endologix) was placed up the contralateral limb to straighten out the angle ad was successful.After the afx2 delivery system was removed the dilator was placed in the sheath to advance the sheath, it was noted that the contralateral limb of the afx2 bifurcated stent graft was smashed.The physician could not advance a pigtail over the stiff wire, as it was getting stuck on the smashed limb.The contralateral limb was ballooned with a 10mm balloon and was able to advance the pigtail.The afx vela suprarenal was delivered and deployed.An angiogram was performed showing a type ib endoleak from the left limb.A 9mm gore vbx stent (non-endologix) was deployed and ballooned to 12mm as the native vessel measured 11.5mm.Another angiogram showed that this did not resolve the type ib endoleak, additionally, there was separation of the vbx and the afx2 main body that resulted in a type iiia endoleak leak.The patient was reported to be stable and not compromised during the procedure.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.

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.Endologix was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the buckling of the left common iliac artery stent, type ib endoleak of the left common iliac artery (resolved) and type iiia endoleak (separation of non endologix stent left limb and afx2 main body) complaints are confirmed.The difficulty in removing the delivery system is unconfirmed.This is moderately consistent with the reported adverse event/incident.The mid aortic angle was 78.2°.This heavy angulation may have contributed to the reported events but could not conclusively be determined.The buckling of the proximal left common iliac artery stent was likely due to the reported issues of removing the main body delivery system.The buckling of the left common iliac stent likely contributed to the type ib endoleak.The overlap between the non-endologix stent and the left limb of the main body was only approximately 10mm, this likely contributed to the type iiia endoleak.The placement of the non endologix stent into the buckled left iliac limb also likely contributed to the reported event.The procedure related harms identified were a myocardial infarction.The final patient status was reported as discharged to rehabilitation on postoperative day three.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: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa).The afx2 bifurcated stent graft was successfully deployed without issue.Difficulty removing the afx2 bifurcated stent graft delivery system post-deployment was experienced.Due to the resistance, the physician felt that the delivery system was pulling on the graft and as though the graft was still connected to the delivery system.In attempt to remove the delivery system the inner core was turned 90 degrees which was unsuccessful; the inner core was moved back and forth while trying to remove the delivery system and was unsuccessful; a lunderquist wire (non-endologix) was placed up the contra limb to straighten out the angle ad was successful.After the afx2 delivery system was removed the dilator was placed in the sheath to advance the sheath, it was noted that the contra limb of the afx2 bifurcated stent graft was smashed.The physician could not advance a pigtail over the stiff wire, as it was getting stuck on the smashed limb.The contra limb was ballooned with a 10mm balloon and was able to advance the pigtail.The afx vela suprarenal was delivered and deployed.An angiogram was performed showing a type ib endoleak from the left limb.A 9mm gore vbx stent (non-endologix) was deployed and ballooned to 12mm as the native vessel measured 11.5mm.Another angiogram showed that this did not resolve the type ib endoleak, additionally, there was separation of the vbx and the afx2 main body that resulted in a type iiia endoleak.The patient was reported to be stable and not compromised during the procedure.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.Reintervention was completed with the implant of an afx2 bifurcated stent graft and an ovation ix extender on (b)(6) 2024.The type ib endoleak and type iiia endoleak with implant separation were successfully resolved.The patient status is reported to be stable.

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.Endologix was unable to perform an evaluation of the devices as they remain implanted in the patient.Additionally, the afx2 stent delivery system was discarded by the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the buckling of the left common iliac artery stent, type ib endoleak of the left common iliac artery and type iiia endoleak (separation of non endologix stent left limb and afx2 main body) complaints are confirmed.The difficulty in removing the delivery system is unconfirmed.The additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.The mid aortic angle was 78.2°.This heavy angulation may have contributed to the reported events but could not conclusively be determined.The buckling of the proximal left common iliac artery stent was likely due to the reported issues of removing the main body delivery system.The buckling of the left common iliac stent likely contributed to the type ib endoleak.The overlap between the non-endologix stent and the left limb of the main body was only approximately 10mm, this likely contributed to the type iiia endoleak.The placement of the non endologix stent into the buckled left iliac limb also likely contributed to the reported event.The procedure related harms identified were a myocardial infarction.The final patient status was reported as discharged home on postoperative day 4 of reintervention in stable condition.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: b5: describe event or problem - additional information b6: relevant tests and lab data - additional information g3: awareness date ¿ updated h10/11: additional manufacturer narrative - updated.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 18025010
• MDR Text Key: 326790750
• Report Number: 3011063223-2023-00019
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)260717
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2023

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
• Device Operator: Health Professional
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 2696440006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 01/24/2024
• Supplement Dates FDA Received: 12/19/2023; 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX INTRODUCER SYSTEM II, LOT # 2642540020; AFX VELA SUPRARENAL, LOT #2591512003; GORE VBX (NON-ENDOLOGIX)
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male