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

Model Number TV-AB2680-N

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it was discarded.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.

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).The aortic body was deployed, and polymer was injected.At the 14 minute mark after the polymer was injected, the integrated balloon was inflated; however, the balloon ruptured before injecting the maximum amount of fluid of (12 ml).It was also noted that there was no excessive ballooning or manipulation performed.There was tortuosity of the aortic neck and no calcification.The physician removed the delivery system and used non-endologix balloon for touch-up.The remainder of the procedure was completed without complications.The device is not available for return.Note: the device did not contribute to death or serious injury but could have based on a similar event(s) with the same failure mode occurring within the last two (2) years that did cause or contribute to death or serious injury of the patient and/or user.

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 device could not be completed.The device was not returned to endologix for evaluation because it was discarded at the user facility.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 balloon rupture is unconfirmed.This is not consistent with the reported adverse event/incident.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 reported 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.

• 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: 16308952
• MDR Text Key: 308940579
• Report Number: 3008011247-2023-00014
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)250714(10)FS071322-10
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB2680-N
• Device Catalogue Number: TV-AB2680-N
• Device Lot Number: FS071322-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Female