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

Model Number TV-AB2980-N

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 06/24/2022

Event Type  malfunction  

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 integrated balloon burst at 16cc while the physician attempted to mold the sealing ring.The ruptured balloon was replaced with a 14fr introducer sheath and a q50 balloon, and the procedure was then completed successfully with no adverse event to patient.The device is not available for return/evaluation.

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation.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.

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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the alto stent graft delivery system was discarded at the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the intraoperative balloon rupture is unconfirmed.This is not consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.Though the intraoperative balloon rupture is unconfirmed it should be noted that for a 29mm alto main body, the recommended integrated balloon volume is 10ml, the maximum is 15ml.The operative report stated 10cc was used; however, it was reported 16cc was.If 16cc was used it was over the maximum suggested volume.The final patient status was reported as being discharged to home on postoperative day one.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.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.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: 15022645
• MDR Text Key: 304459108
• Report Number: 3008011247-2022-00080
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)250426(10)FS042322-14
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV-AB2980-N
• Device Lot Number: FS042322-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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, SN: (B)(6).; OVATION IX ILIAC LIMB, SN: (B)(6).; OVATION PRIME FILL POLYMER, SN: (B)(6).
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female