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

Model Number TV-AB3480-N

Device Problem Filling Problem (1233)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2023

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 physician noticed that the polymer filled the sealing ring, support ring and ipsilateral side, but not the contralateral side.Despite the syringe not being entirely empty, the patient remained stable, and polymer leakage was not suspected.Attempts were made to resolve the issue, but the alto device's body could not be pushed furthe.A cross-over lumen and guidewire were used to access the contralateral leg, but due to a lack of support on that side, the snare delivery catheter couldn't be inserted.After 14 minutes, ballooning was performed, and eventually, the snare delivery catheter was successfully advanced into the contralateral leg, allowing for the placement of the following limbs.The procedure was concluded and no injury to the patient was observed.The delivery system is unavailable for return/evaluation.

Manufacturer Narrative

The delivery system devices involved in this event will not be returned for evaluation and were discarded.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.H3 other text : 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's 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 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 the alto, with no polymer fill in the contralateral limb, is confirmed.This is consistent with the reported adverse event/incident.The stent graft was positioned with ro markers just below the renal artery.The infrarenal angle at p2+40 was 70°.This could have contributed to the reported event, but that 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 remains unknown.The final patient status was not made available to endologix.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 ¿ updated h6: investigation finding codes - remove code (b)(4) h6: investigation conclusion codes - remove code 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: 17946111
• MDR Text Key: 325826796
• Report Number: 3008011247-2023-00181
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)241025(10)FS102121-12
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120006
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS102121-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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 PRIME FILL POLYMER LN FF100322-03
• Patient Outcome(s): Other