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

Model Number	TV-AB2680-N
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/17/2021
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.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 implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately (2) two months post initial procedure during a routine follow-up, a type 2 endoleak (non ¿ device-related failure) and a possible type 1a endoleak were identified.The patient is currently being monitored while intervention is being discussed.
Additional Manufacturer Narrative
The physician confirmed there was a (non-device-related) type 2 endoleak.Therefore, a complaint is no longer warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately (2) two months post initial procedure during a routine follow-up, a type 2 endoleak (non ¿ device-related failure) and a possible type 1a endoleak were identified.The patient is currently being monitored while intervention is being discussed.Additional information: the physician does not feel there is a type 1a endoleak.The physician confirmed there was a (non-device-related) type 2 endoleak.Therefore, a complaint is no longer warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.

• Brand Name: ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12434157
• Report Number: 3008011247-2021-00106
• Device Sequence Number: 17164398
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680N1
• UDI-Public: +M701TVAB2680N1/$$3240304FS03022120Z
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/25/2021

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: 03/04/2024
• Device Model Number: TV-AB2680-N
• Device Catalogue Number: TV-AB2680-N
• Device Lot Number: FS030221-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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: OVATION IX ILIAC LIMB FS110520-33.; OVATION IX ILIAC LIMB FS120120-33.; OVATION IX EXTENDER FS092920-19.; OVATION IX ILIAC LIMB FS112818-24.; OVATION PRIME FILL POLYMER FF011821-01.; OVATION IX ILIAC LIMB FS110520-33; OVATION IX ILIAC LIMB FS120120-33; OVATION IX EXTENDER FS092920-19; OVATION IX ILIAC LIMB FS112818-24; OVATION PRIME FILL POLYMER FF011821-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR