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

Model Number TV-AB2380

Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Deformation Due to Compressive Stress (2889)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/12/2023

Event Type  Injury  

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that one (1) iliac limb was implanted due to a kink in the contralateral gate.The contralateral gate seemed completely closed and there was no passage of blood.The physician elected to perform a fem-fem bypass and proceeded to end the procedure and evaluate the patient at a later stage.It was also reported there was a small type 1a endoleak noted intraoperatively; however, the physician elected to observe the endoleak to see if it would self resolve over time.

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.

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 remains implanted.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 left common iliac artery stent buckling, left limb occlusion and femoral to femoral bypass are confirmed.The type 1a endoleak is unconfirmed.This is moderately consistent with the reported adverse event/incident.The complaint is most likely anatomy related.The contralateral limb was beat out for space by the ipsilateral limb.The outer diameter of the limbs when filled polymer are approximately 14-15mm in diameter.The pre ct showed an area of approximately 14.5mm where the limbs would be competing for space.Since the ipsilateral limb fills first, this took up the "space" thus limiting the ability to cannulate the contralateral limb.Procedure related harms for this complaint could not be determined.The final patient status was reported as 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.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: 18418808
• MDR Text Key: 331603558
• Report Number: 3008011247-2023-00214
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• 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: 12/12/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: TV-AB2380
• Device Lot Number: FS090723-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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 # FS051123-11; OVATION PRIME FILL POLYMER, LOT # FF031423-01
• Patient Outcome(s): Required Intervention