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

Model Number	TV-AB2680-N
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
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.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 aortic main body was not returned to endologix for evaluation because it remains implanted and the delivery system was discarded at the user facility.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 reported empty syringe (suspected polymer leak), hypotension with successfully treatment were confirmed.This is consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was discharged home stable on the third post operative day.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.
Event or Problem Description
An ovation alto abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied.The patient experienced hypotension evidenced by a drop in blood pressure, and was successfully treated for an anaphylactic reaction per the device ifu.The aneurysm was successfully excluded at the conclusion of the implant procedure.The patient is currently stable and without symptoms.

• Brand Name: OVATION ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11334924
• Report Number: 3008011247-2021-00012
• Device Sequence Number: 19678938
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680N1
• UDI-Public: +M701TVAB2680N1/$$3230729FS07272015G
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 01/18/2021

1 Device 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: 07/29/2023
• Device Model Number: TV-AB2680-N
• Device Catalogue Number: TV-AB2680-N
• Device Lot Number: FS072720-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No