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

Model Number TV-AB2680-N

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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 being implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that the patient had a short aortic neck measuring approximately 10mm, with the left renal artery being a couple of millimeters lower than the right.There was both thrombus and calcium at the levels of both renals.The procedure went well and no endoleaks were noticed; however, the left renal was barely visible.The physician took a simmons 2 (non-endologix) catheter up and got a picture of the left renal at the end of the procedure and left the case confident that all was well.It was reported that the next day the patient had stopped making urine.An ultrasound was taken and showed there was no flow in both renals.A computed tomography (ct) scan was not taken because the patients¿ creatinine had also risen.The physician stated there was clot in both renals, and that the left was slightly worse than the right.It is unknown if the stent graft had covered the renals as the physician had not looked.It was noted that with the manipulation of the graft, along with the calcium and thrombus, there were flow compromised.The physician elected to perform bypasses on both renals to resolve this event.The final patient status was reported as stable and doing well.

• 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: 18958293
• MDR Text Key: 338341547
• Report Number: 3008011247-2024-00030
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)260818(10)FS081423-22
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TV-AB2680-N
• Device Lot Number: FS081423-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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, LOT # FS011623-46; OVATION IX ILIAC LIMB, LOT # FS070523-07; OVATION PRIME ILIAC LIMB, LOT # FF111423-03
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male