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

Model Number	TV-AB2680-N
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024.Reportedly this was an off label case as the non conic shape diameter growth is 12.8% and should be = 10%.And the max iliac diameter measured at 7.5mm and should be = 8mm and = 25mm.The alto main body sealing ring was placed over the left renal and a gore (non-endologix) vbx 5x29 mm stent was placed to create a chimney.The procedure was completed with the implant of the ovation ix iliac limbs.A small type ia endoleak was seen at the end of the procedure.The patient will be monitored and a 30 day follow up computed tomography angiogram (cta) will be performed see if the type ia endoleak resolves.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.H3 other text : device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024.Reportedly this was an off label case as the non conic shape diameter growth is 12.8% and should be = 10%.And the max iliac diameter measured at 7.5mm and should be = 8mm and = 25mm.The alto main body sealing ring was placed over the left renal and a gore (non-endologix) vbx 5x29 mm stent was placed to create a chimney.The procedure was completed with the implant of the ovation ix iliac limbs.A small type ia endoleak was seen at the end of the procedure.The patient will be monitored and a 30 day follow up computed tomography angiogram (cta) will be performed see if the type ia endoleak resolves.Additional information has been received reporting that the follow up cta showed that the intraoperative type ia endoleak has resolved.
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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the intraoperative type ia endoleak complaint is confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely user related.No procedure related harms were identified.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The non-conic shape is 12.8% (should be = 10%).And there was a pararenal aneurysm.Additionally, the alto main body second support ring was placed over the left renal artery and a non-endologix stent was placed to create a chimney.This likely contributed to the reported intraoperative type ia endoleak.The left common iliac artery was off label measuring at 7.5mm (should be 2-25 mm).It is unlikely this contributed to the reported event.The final patient status was reported as discharged home on postoperative day 5 with home health care support.It was reported the type ia endoleak was resolved on the 30 day follow up, but this cannot be conclusively determined due to lack of imaging for review.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 - additional information.G3: awareness date ¿ updated.H6: medical device problem codes ¿ remove 4065.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 ; 8009832284
• MDR Report Key: 18572254
• Report Number: 3008011247-2024-00010
• Device Sequence Number: 17926898
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)251012(10)FS101022-49
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2024

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 Expiration Date: 10/12/2025
• Device Model Number: TV-AB2680-N
• Device Lot Number: FS101022-49
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: GORE (NON-ENDOLOGIX) VBX (LN UNK).; OVATION IX ILIAC LIMB (LN (B)(4)).; OVATION IX ILIAC LIMB (LN (B)(4)).; OVATION PRIME FILL POLYMER (LN (B)(4)).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female