MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2024

Event Type  Injury  

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.

Event Description

The patient underwent treatment for an abdominal aortic aneurysm (aaa) with the implantation of an afx2 bifurcated stent graft on (b)(6) 2024.It was reported that during deployment of the contralateral limb, resistance was encountered, and the cover could not be fully pulled out.Despite attempts to adjust the sheath position and retrieve the cover using a snare, the cover remained partially deployed, with a part of it (the proximal portion) missing.To address this issue, a catheter was inserted from the contralateral side, and percutaneous transluminal angioplasty (pta) was performed to facilitate the deployment of the contralateral limb.During pta, it was noted that the proximal portion of the cover was possibly torn off, resulting in graft expansion, but a portion of the cover remained inside the body between the vessel wall and the graft.A balloon touch-up was performed to ensure full limb deployment, and the procedure was completed with the implantation of two afx vela infrarenal grafts.No endoleak was observed, and the patient's post-operative condition is stable.Return of the delivery system is expected.

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 returned device was completed.Endologix received only the yellow contralateral cover for an afx2 delivery system.It was securely packaged in a box and double-bagged.Upon inspection, the presence of blood and tissue residue was noted, necessitating decontamination procedures.Following this, a thorough visual examination was conducted.As only the contralateral cover was returned without accompanying devices, endologix was unable to replicate the reported issue.Despite the thorough visual analysis, the root cause of this matter remained undetermined.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix confirms the complaint involving the afx2 delivery system, difficulty in withdrawing the contralateral limb, difficulty in deploying the contralateral limb, and detachment of components (the proximal portion of the cover remains in the patient).This is consistent with the reported adverse event/incident.There were significantly thickened calcifications at the bifurcation and in the left common iliac artery.This could have contributed to the reported event but could not be conclusively determined.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 reported as stable.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 type codes: remove code 4118, h6: investigation finding codes: remove code 3233, h6: investigation conclusion codes: remove code 11.

• 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: 18961807
• MDR Text Key: 338386274
• Report Number: 3011063223-2024-00041
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)261026
• 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
• Report Date: 03/07/2024

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: BEA28-100/I20-40
• Device Lot Number: 2729660-008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• 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: 80 YR
• Patient Sex: Male