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

Model Number	TV-AB3480-N
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto abdominal aortic aneurysm stent system.During the initial implant procedure, there was a partial fill of the alto graft and an intraoperative type ia endoleak.The physician elected to implant a palmaz stent, however the endoleak remained unresolved.The patient will continue to be monitored at 30-day follow-up.
Additional Manufacturer Narrative
B5: describe event or problem - updated g4: date received by manufacturer - updated h6: patient code: remove 1924 note: as the type 1a endoleak had self-resolved at the 30 day follow up with no further intervention; therefore, this is no longer a reportable event.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto abdominal aortic aneurysm stent system.During the initial implant procedure, there was a partial fill of the alto graft and an intraoperative type ia endoleak.The physician elected to implant a palmaz stent, however the endoleak remained unresolved.The patient will continue to be monitored at 30-day follow-up.Subsequent to the initial report, additional information was received reporting that the 30-day follow-up showed that the intraoperative type ia endoleak had resolved and that the patient is doing well.The physician will perform a 60-day follow-up.

• Brand Name: ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12331732
• Report Number: 3008011247-2021-00090
• Device Sequence Number: 14697597
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480N1
• UDI-Public: +M701TVAB3480N1/$$3240310FS030821440
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 03/10/2024
• Device Model Number: TV-AB3480-N
• Device Catalogue Number: TV-AB3480-N
• Device Lot Number: FS030821-44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FILL POLYMER, SN (B)(6) ; OVATION IX ILIAC LIMB, SN (B)(6) ; OVATION IX ILIAC LIMB, SN B)(6) ; FILL POLYMER, SN B)(4) ; OVATION IX ILIAC LIMB, SN (B)(4) ; OVATION IX ILIAC LIMB, SN B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR