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

Model Number	TV-AB2980-N
Medical Device Problem Codes	Filling Problem (1233); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional 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.The device was not returned to endologix for evaluation, as 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 malposition of the device (contralateral limb deployed in ipsilateral limb) and filling problem (no polymer fill in the contralateral limb) complaints are unconfirmed.This is not consistent with the reported adverse event/incident it was reported that the delivery system was inserted without confirming the correct orientation, which led to misalignment.To correct the discrepancy in marker positioning, the entire sheath was rotated.However, this rotation did not ensure proper alignment, resulting in the contralateral leg of the device being deployed in the wrong limb (the right limb instead of the intended contralateral left side).While this may have contributed to the reported event, it could not be conclusively determined.It was reported that no polymer was injected into the contralateral limb.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status was not reported however, it was reported that the procedure was completed successfully without any endoleak.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.
Event or Problem Description
The patient underwent an endovascular aneurysm repair (evar) procedure on (b)(6) 2023, involving the implantation of the alto abdominal stent graft system.During the procedure, the delivery system was inserted without verifying contralateral orientation, resulting in misalignment of the marker position.To address this, the entire sheath was rotated.Following main body deployment, a slow polymer injection caused the contralateral leg to deploy on the unintended right side instead of the planned left.Although polymer was not injected into the contralateral leg, the rim was placed as intended.The procedure was completed successfully without any endoleak.

• Brand Name: ALTO
• Common Device Name: 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
• MDR Report Key: 20686538
• Report Number: 3008011247-2024-00117
• Device Sequence Number: 7234872
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)260310(10)FS030823-24
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2026
• Device Model Number: TV-AB2980-N
• Device Lot Number: FS030823-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB LOT# FS011323-46.; OVATION IX ILIAC LIMB LOT# FS062321-27.; OVATION IX ILIAC LIMB LOT# FS113022-56.; OVATION PRIME FILL POLYMER (LN FF010423-01).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male