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

Model Number	TV-AB3480-N
Medical Device Problem Codes	Short Fill (1575); Deformation Due to Compressive Stress (2889); Migration (4003)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient and the delivery system was discarded.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 or Problem Description
The patient was being implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that the contralateral limb of the alto main body did not fill with polymer.The "up and over" lumen was used to wire the contralateral gate and successfully place the contralateral limb.One day later the patient presented with buttock claudication/pain and diminished pulses in the right groin and foot.The right iliac was found to have migrated and kinked at the bifurcation of the aortic body.The physician elected to implant 11x59mm vbx (non-endologix) stents bilaterally raising the bifurcation of the aortic body and remedying the problem.
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.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 no polymer fill of the contralateral limb is confirmed.Device, user, procedure or anatomy relatedness of the no fill could not be determined.The limb migration, kinking, claudication of the buttock and additional endovascular procedures are unconfirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms could not be identified.The infrarenal angulation of 65.6 degrees could have contributed to the reported event but could not be conclusively determined.The contralateral limb appeared to be placed approximately 6mm below the ipsilateral limb.Due to the limited imaging it could not be conclusively determined that this was indeed the case or if it contributed to the reported event.An additional procedure resolved the reported problem.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
• 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: 20580113
• Report Number: 3008011247-2024-00111
• Device Sequence Number: 8096366
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)270201(10)FS013024-39
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS013024-39
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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 # FS022024-38.; OVATION IX ILIAC LIMB, LOT # FS102023-23.; OVATION PRIME FILL POLYMER, LOT # FF111723-01.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male