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

Model Number	TV-AB2980-N
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/27/2021
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).During this initial procedure, there was a type 1a endoleak.The physician elected to implant a non endologix (palmaz) stent.The endoleak improved but it did not completely resolve.The patient is currently being monitored and the endoleak will be re-evaluated at the 30 day follow up visit.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).During this initial procedure, there was a type 1a endoleak.The physician elected to implant a non endologix (palmaz) stent.The endoleak improved but it did not completely resolve.The patient is currently being monitored and the endoleak will be re-evaluated at the 30 day follow up visit.Subsequent to the initial report, additional information was provided stating that the type ia endoleak has resolved on its own and reintervention was not required.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted in the patient.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status remains unknown.The final patient status was not made available to endologix.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 - updated.G4: date received by manufacturer - updated.Note: as the type 1a endoleak had self-resolved at the 30 day follow up with no further intervention, a complaint is not warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.This is no longer a reportable event.

• Brand Name: ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12305342
• Report Number: 3008011247-2021-00088
• Device Sequence Number: 3181605
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980N1
• UDI-Public: +M701TVAB2980N1/$$3230715FS071420037
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/27/2021

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: 07/15/2023
• Device Model Number: TV-AB2980-N
• Device Catalogue Number: TV-AB2980-N
• Device Lot Number: FS071420-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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, LOT # FS051420-11; OVATION IX ILIAC LIMB, LOT # FS060221-02; OVATION PRIME FILL POLYMER, LOT # FF040320-01; OVATION IX ILIAC LIMB, LOT # FS051420-11; OVATION IX ILIAC LIMB, LOT # FS060221-02; OVATION PRIME FILL POLYMER, LOT # FF040320-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR