MAUDE Adverse Event Report: ENDOLOGIX AFX2; DELIVERY SYSTEM

Model Number BEA22-90/I16-30

Device Problems Difficult or Delayed Activation (2577); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2023

Event Type  Injury  

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft.It was reported that the delivery system was rotated one (1) turn to adjust the contralateral wire orientation.It was then rotated one and half (1.5) turns more.After positioning the device, the physician pulled the control cord, but the cord stopped around the third stent.The physician moved the inner core upwards and downwards with additional rotations; however, this did not release the cord.The physician decided to deploy the contralateral limb successfully.The wire lock was released as expected.The physician then tried to pull the control cord again but was unsuccessful.A non-endologix balloon was inserted from the contralateral limb and inflated around the thoracic aorta (ta).It was noted that the afx2 bifurcated stent graft appeared to be fully deployed, but the cover was unable to be retrieved.The physician pulled the cord again after deploying the ipsilateral limb, but this did not retrieve the cover.The physician then attempted to pull the inner core down, and it was able to move it down to the middle of bifurcated stent graft.The physician decided to cut the control cord the delivery system was pulled once again; however, it got stuck at the tip of the afx introducer sheath.Both devices were removed from the patient together.The detached red cover remained inside the patient's body.No endoleak was observed at the final angiogram and the physician decided to end the procedure.Return of the delivery system is expected.

Manufacturer Narrative

The delivery system is expected to be returned for evaluation.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 h3 other text : device not yet received.

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.The stent graft remains implanted and the delivery system was returned to endologix for evaluation.Endologix received one (1) afx2 bifurcated stent graft system without the stent graft and one (1) afx introducer system securely packaged within double-bagged and boxed packaging.Upon inspection, the presence of blood and tissue residue was noted, necessitating decontamination procedures.Following this, a thorough visual examination and a limited functional analysis were conducted.It was observed that the yellow contra wire sleeve, as well as the detached red cover, were not returned.The sheath/shaft exhibited kinks in the vicinity of its proximal tip.Attempts to advance and retract the system were unsuccessful, leading to additional kinks along the sheath/shaft.Endologix was able to confirm the issues of "difficult to deploy," "unable to withdraw," and "detachment of components." the root cause for these issues could not be determined based on the visual and functional analysis.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 delivery system unable to withdraw and difficult to deploy are confirmed.The detachment of components (main body red cover) is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest stent graft buckling mid aorta and type 2 (non-device related) endoleak of the lumbar and inferior mesenteric artery occurred that was not included in the event as reported.The stent graft buckling and type 2 endoleak was discovered during review of the post implant ct scan.The type 2 endoleak is anatomy related.The aorta and iliac arteries were heavily calcified with thickened chunks, and at times nearly circumferential.It is unclear if this contributed to the reported event.It was reported the delivery system was rotated one turn to adjust the contralateral wire orientation.It was then rotated 1.5 turns more.The ifu does clearly state if necessary to resolve wire orientation by rotating the delivery system handle and the afx introducer sheath as a unit.It is unclear from the description if there was excessive turning of the handle and sheath which could have contributed to the reported event.Additionally, the main body red cover is not radiopaque and is not visible on ct scan.Device, user procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.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.Correction: g3: awareness date has been updated.H10/h11: additional manufacturer narrative has been updated.

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.The stent graft remains implanted and the delivery system was returned to endologix for evaluation.Endologix received one (1) afx2 bifurcated stent graft system without the stent graft and one (1) afx introducer system securely packaged within double-bagged and boxed packaging.Upon inspection, the presence of blood and tissue residue was noted, necessitating decontamination procedures.Following this, a thorough visual examination and a limited functional analysis were conducted.It was observed that the yellow contra wire sleeve, as well as the detached red cover, were not returned.The sheath/shaft exhibited kinks in the vicinity of its proximal tip.Attempts to advance and retract the system were unsuccessful, leading to additional kinks along the sheath/shaft.Endologix was able to confirm the issues of "difficult to deploy," "unable to withdraw," and "detachment of components." the root cause for these issues could not be determined based on the visual and functional analysis.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 unable to withdraw, difficult to deploy and detachment of components (main body red cover) are unconfirmed.This is not consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest stent graft buckling mid aorta and type 2 (non-device related) endoleak of the lumbar and inferior mesenteric artery occurred that was not included in the event as reported.The stent graft buckling and type 2 endoleak was discovered during review of the post implant ct scan.The type ii endoleak is anatomy related.The aorta and iliac arteries were heavily calcified with thickened chunks, and at times nearly circumferential.It is unclear it this contributed to the reported event.It was reported the delivery system was rotated one turn to adjust the contralateral wire orientation.It was then rotated 1.5 turns more.The ifu does clearly state if necessary to resolve wire orientation by rotating the delivery system handle and the afx introducer sheath as a unit.It is unclear from the description if there was excessive turning of the handle and sheath which could have contributed to the reported event.Additionally, the main body red cover is not radiopaque and is not visible on ct scan.Device, user procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.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: d9: device available for eval has been updated.D9: date received has been updated.G3: awareness date has been updated.H3: device evaluated by mfg has been updated.H3: device ret to mfg for eval has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: AFX2
• Type of Device: DELIVERY SYSTEM
• 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: 18279106
• MDR Text Key: 329890558
• Report Number: 3011063223-2023-00044
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2697011008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/05/2024; 03/12/2024
• Supplement Dates FDA Received: 02/02/2024; 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female