MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; MAIN BODY DELIVERY SYSTEM

Model Number TV-AB3480-N

Device Problem Activation Problem (4042)

Event Date 05/02/2023

Event Type  Injury  

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, the main body was unsheathed and the mid-crown successfully deployed once the first nested knob was pulled.The graft markers were ballooned, adjustments were made for parallax and another angiogram was taken.The physician then placed the device for deployment and the second nested knob was pulled, but the proximal crown of the stent graft did not release.In response, the physician rotated the handle back and forth, believing the nitinol belts were trapped.Again, the stent graft did not deploy.The polymer was injected to visualize the graft, and physician attempted for more than two (2) hours to steer the wire through the constrained proximal crown and proximal portion of the nitinol belts to the delivery system.The physician stabilized the stent graft with a q69x balloon and disconnected the device from the delivery system by deploying the third nested knob.The belts then became fractured, which released the proximal crown.Both iliac limbs were successfully implanted.Due to the difficult deployment issue, the physician opted to not use the integrated balloon on the sealing rings, and this led to a small residual type ia endoleak.A palmaz (non-endologix) stent was implanted, which significantly reduced the endoleak, however it remained unresolved.The physician chose to not balloon the sealing rings more aggressively, believing the endoleak would self-resolve due to its small size.It was also noted that the patient was intubated for multiple hours with exposure to radiation.In total, the procedure took approximately five (5) hours to complete.Patient has since been extubated, is in icu (intensive care unit) and reportedly stable with no additional issues.The delivery system is not available for return/evaluation as the hospital retained the device.

Manufacturer Narrative

The delivery system involved in this event will not be returned for evaluation and was retained by the user facility.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Delivery system unavailable.

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 complaint device could not be completed as it was not returned to endologix.However, testing was performed using an alto delivery system retained by endologix.The evaluation of the deployment failure of the incident was successfully replicated during an internal investigation, confirming that the release wires 2 and 3 were likely routed incorrectly (swapped) for the complaint device.This condition would result in release wire 2 routed to release knob 3, and release wire 3 routed to release knob 2.When the release/nested knob 2 was pulled, it released the stent graft retention attachment instead of the proximal stent crown.The release of the stent graft retention attachment is not visible during a clinical procedure.Therefore, releasing the stent graft attachment during release knob 2 pulling would result in a false perception of the failure to release as stated in the complaint.When the final release knob 3 was pulled, the proximal stent crown was released instead of the expected graft retention attachment.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported alto, difficulty to deploy proximal crown and type ia endoleak are unconfirmed.This is not consistent with the reported adverse event/incident.Though device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review, the device evaluation of the alto delivery system retained by endologix determined the most likely cause of the difficulty to deploy the crown was due to the release wires being routed incorrectly.Procedure- related harms identified were prolonged procedure.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.Corrections: g3 awareness date h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 11.

• Brand Name: ALTO
• Type of Device: MAIN BODY DELIVERY SYSTEM
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 16984774
• MDR Text Key: 315845565
• Report Number: 3008011247-2023-00065
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)250914(10)FS090922-29
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: TV-AB3480-N
• Device Catalogue Number: TV-AB3480-N
• Device Lot Number: FS090922-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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: OVATION IX ILIAC LIMB, LN FS080422-77; OVATION IX ILIAC LIMB, LN FS081722-56; OVATION PRIME FILL POLYMER, LN FF081622-01
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR