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

Model Number TV-AB2680-N

Device Problem Material Invagination (1336)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 12/06/2022

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 ,the patient was admitted into the hospital with flank pain and a computed tomography angiogram (cta) demonstrated the presence of an aaa.The patient was hemodynamically stable and the physician scheduled an urgent procedure for the next morning.After the alto stent graft system was implanted, the final angiogram run appeared to show possible infolding of the main body seal ring and there appeared to be contrast outside of the seal ring; however, it terminated above the secondary seal ring.There was no endoleak into aaa sac.Immediately after the procedure the patient¿ flank pain was gone.The patient woke up the next day with flank pain and an urgent cta was performed which demonstrated a type 1a endoleak in the area around the infold of the primary seal ring.The patient was brought back the next day and the physician elected to place a palmaz (non-endologix) stent in proximal portion of alto aortic body to successfully resolve the endoleak.The patient's status was reported as doing well.

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 type 1a endoleak (resolved with non-endologix palmaz stent) with additional endovascular procedure and the infolding of the proximal ring are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 2 endoleak (non-device related) from the lumbar artery that occurred that was not included in the event as reported.The type 2 endoleak was discovered during review of the ct (computed tomography) scan dated 12/07/2022.The most likely causation for the type 1a endoleak is likely user related.The juxtarenal angle was 71.6° (should be less than 60°)-off label.This likely contributed to the type 1a endoleak.It was reported that there was a very short, angulated neck and severe tortuosity of the aorta.This likely contributed to the reported events.Type 2 endoleak of the lumbar artery is anatomy related.No procedure related harms for this complaint were identified.The final patient status was reported to be discharged to home stable postoperative day one.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: b5: describe event or problem has been updated.G3: date received by manufacturer has been updated.H6: health effect - clinical code: remove code1924.H6: investigation finding: remove code 3233.H6: investigation conclusion: remove code 11.

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported ,the patient was admitted into the hospital with flank pain and a computed tomography angiogram (cta) demonstrated the presence of an aaa.The patient was hemodynamically stable and the physician scheduled an urgent procedure for the next morning.After the alto stent graft system was implanted, the final angiogram run appeared to show possible infolding of the main body seal ring and there appeared to be contrast outside of the seal ring; however, it terminated above the secondary seal ring.There was no endoleak into aaa sac.Immediately after the procedure the patient¿ flank pain was gone.The patient woke up the next day with flank pain and an urgent cta was performed which demonstrated a type 1a endoleak in the area around the infold of the primary seal ring.The patient was brought back the next day and the physician elected to place a palmaz (non-endologix) stent in proximal portion of alto aortic body to successfully resolve the endoleak.The patient's status was reported as doing well.Additional information: an internal clinical evaluation determined there was reasonable evidence to suggest a type 2 endoleak (non-device related) from the lumbar artery that occurred that was not included in the event as reported.The type 2 endoleak was discovered during review of the ct (computed tomography) scan dated 12/07/2022.

• 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: 16022711
• MDR Text Key: 305889389
• Report Number: 3008011247-2022-00169
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/06/2022

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-AB2680-N
• Device Lot Number: FS072822-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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 # FS060722-40; OVATION IX ILIAC LIMB, LOT # FS080322-28; OVATION IX ILIAC LIMB, LOT # FS080322-48; OVATION PRIME FILL POLYMER, LOT # FF032822-01
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR