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

Model Number TV-AB2980-I

Device Problem Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Failure of Implant (1924)

Event Date 02/09/2021

Event Type  Injury  

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 Description

The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).An intraoperative type 1a endoleak was identified.The physician elected to implant a non- endologix bare metal stent (palmaz) and perform ballooning however a small intraoperative type 1a endoleak was still present.The procedure was complete and the patient will be monitored.The patient will be re-evaluated at the 30 day follow up.

Event Description

The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).An intraoperative type 1a endoleak was identified.The physician elected to implant a non-endologix bare metal stent (palmaz) and perform ballooning however a small intraoperative type 1a endoleak was still present.The procedure was complete and the patient will be monitored.The patient will be re-evaluated at the 30 day follow up.Additional information received indicating that the ct (computed tomography) scan completed 48 hours post initial implant shows there is little to no sign of a remaining type ia endoleak.The patient is reportedly doing well.

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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix does not confirm the reported type 1a endoleak.The clinical evaluation also shows reasonable evidence to suggest thickened calcifications in the aortic neck (cautionary product use), but it is unknown if this contributed to the reported event.This finding was discovered during an examination of the procedure planning dated (b)(6) 2020.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was reported to be doing well under surveillance.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.Correction: b5, g3, g4, h6; h6 evaluation result codes - remove 3233 h6 evaluation conclusion codes - remove 11.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11425740
• MDR Text Key: 247669137
• Report Number: 3008011247-2021-00018
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980I1
• UDI-Public: +M701TVAB2980I1/$$3220829FS08281908Q
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2022
• Device Model Number: TV-AB2980-I
• Device Lot Number: FS082819-08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB, SN (B)(6).; OVATION IX ILIAC LIMB, SN (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR