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

Model Number TV-AB3480-N

Device Problems Filling Problem (1233); Patient-Device Incompatibility (2682)

Patient Problem Ruptured Aneurysm (4436)

Event Date 02/28/2024

Event Type  Injury  

Event Description

The patient underwent treatment for a rupture with the implantation of the alto abdominal stent graft system on (b)(6) 2024.This initial procedure falls outside the indications of use (off-label) as stated in the instructions for use (ifu), due to the utilization of the alto main body device to address a rupture.The patient presented with challenging anatomical features, including an angled neck and aorta, as well as an extremely tortuous iliac.Deployment of the alto main body was successful; however, during polymer fill, the contralateral limb failed to fill.The attending physician encountered difficulty accessing the limb and suspected occlusion due to its angle.A fem-fem procedure was performed, effectively sealing the abdominal aortic aneurysm (aaa).Post-procedure, the patient's condition was reported to be stable.

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.H3 other text : device remains implanted.

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.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; filling problem (no fill of the contralateral limb), and buckling complaints are unconfirmed.The right femoral to left femoral bypass complaint and contralateral limb occlusion complaints are confirmed.This is monetarily consistent with the reported adverse event/incident.The device, user, procedure, or anatomy-relatedness of the filling problem and buckling could not be determined.The bypass and occlusion complaints are most likely anatomy-related.Procedure-related harms are left limb occlusion and infection (gram-negative rod bacteremia in blood culture).It was reported there was no polymer fill in the contralateral limb.This most likely contributed to the difficulty in cannulating the contralateral limb resulting in a left iliac limb occlusion and fem-fem bypass.There was a bilobed abdominal aortic aneurysm.The aorta and iliac were severely angulated and tortuous.The infrarenal angulation was 51.7° and suprarenal angulation was 51.7°.It is likely the multiple severe angulations in the aorta and iliac contributed to the difficulty in cannulating the contralateral anatomy.The final patient status was reported as discharged to home on postoperative day nine on intravenous antibiotics.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 has been updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion codes: remove code 11.

• 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: 18955939
• MDR Text Key: 338309124
• Report Number: 3008011247-2024-00027
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)261122(10)FS111623-62
• 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: 02/29/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS111623-62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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 FS092122-61; OVATION IX ILIAC LIMB FS111822-30; OVATION PRIME ACCESSORY DEVICE DP-20404; OVATION PRIME FILL POLYMER FF070623-01
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male