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

Model Number TV-AB2680-L

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Inflammation (1932); Pain (1994)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

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 has not been received yet.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with the implant of the alto stent graft system.Before proximal crown deployment, the anesthesiologist treated the patient with nitroglycerine to manage high blood pressure.The surgical team then encountered difficulties with the tube connection, which was found to be faulty; this occurred prior to the first balloon inflation.The team therefore decided to cut the tube connection and attach the syringe directly to the tube.During the polymer filling stage, the anesthesiologist notified the surgical team that the patient's blood pressure was low at 30/130.They suspected a polymer leak, but after inspecting the syringe, none was found.Shortly after, the patient experienced back burning, and it was discovered that the syringe was empty, indicating a polymer leak.The patient was also reported to have no skin rash but a swollen tongue.The surgeons disconnected the autoinjector and administered noradrenaline, but the patient's blood pressure remained low, prompting intubation.The rings were successfully filled, post-dilation was deemed unnecessary, and the iliac limbs were placed, with a perfect seal achieved.The patient was transferred to intensive care and remained stable.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with the implant of the alto stent graft system.Before proximal crown deployment, the anesthesiologist treated the patient with nitroglycerine to manage high blood pressure.The surgical team then encountered ifficulties with the tube connection, which was found to be faulty; this occurred prior to the first balloon inflation.The team therefore decided to cut the tube connection and attach the syringe directly to the tube.During the polymer filling stage, the anesthesiologist notified the surgical team that the patient's blood pressure was low at 30.They suspected a polymer leak, but after inspecting the syringe, none was found.Shortly after, the patient experienced back burning, and it was discovered that the syringe was empty, indicating a polymer leak.The patient was also reported to have no skin rash but a swollen tongue.The surgeons disconnected the autoinjector and administered noradrenaline, but the patient's blood pressure remained low, prompting intubation.The rings were successfully filled, post-dilation was deemed unnecessary, and the iliac limbs were placed, with a perfect seal achieved.The patient was transferred to intensive care and remained stable.

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 one (1) alto delivery system for an evaluation.The device was shipped in a large shipping box, within the original product box, within a biohazard bag, wrapped in a transparent plastic bag, within the original product tray.There was blood residue present on the device and on the tray.The stent graft was not returned as it was implanted in the patient as reported.The sheath was returned separated from the device.An empty 10ml syringe was returned.An empty 30ml syringe was returned and it was still connected to the polymer fill port on the delivery system.There was visible polymer in the polymer fill tube on the delivery system.The balloon port was returned separated from the delivery system.The balloon fill tube appeared cut at approximately 3mm from the base of the balloon port.A visual and limited functional analysis were performed.Upon visual inspection it was noted that the balloon fill line luer was separated from the pvc balloon fill line without mention in the complaint as to the reason.There is a kink in the guide wire lumen and the oval balloon fill lumen approximately 19mm proximal to the proximal lumen spacer.The remainder of the device appears unremarkable.The handle halves were separated to inspect the inner chassis for any sign of a polymer leak but none was noted.All appeared as expected.There is cured polymer present beginning at the base of the syringe plunger and continuing down the entire length of the polymer flow lumen, with cured polymer present at the end of the tapered polyimid polymer fill line.The sheath and sheath assembly appear unremarkable.Based on the evaluation performed it was not possible to confirm the complaint of polymer leak.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, intraoperative polymer leak 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.No contributing factors were identified.The final patient status was reported to be 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
• 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: 16865093
• MDR Text Key: 314525095
• Report Number: 3008011247-2023-00047
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370947
• UDI-Public: (01)00850007370947(17)250815(10)FS081122-72
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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-AB2680-L
• Device Lot Number: FS081122-72
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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 ANCILLARIES (B)(6); OVATION IX ILIAC LIMB FS080822-84; OVATION IX ILIAC LIMB FS100422-12; OVATION PRIME FILL POLYMER FF062122-02
• Patient Outcome(s): Required Intervention
• Patient Sex: Male