MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number TV-AB3480-J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.

Event Description

During implant of the ovation ix sealing system to treat an abdominal aortic aneurysm, a type ia endoleak was identified after the limb was placed.A coda balloon was used to balloon the sealing rings but the type ia endoleak was not sealed.The physician continued with the case and placed the ipsilateral limb and proceeded to deploy a non-endologix (palmaz) stent; however, the type ia endoleak was still there.The patient will be monitored and a 30 day follow-up ct scan will be performed.Reportedly, the patient had trouble breathing and lying flat pre and post procedure.

Event Description

Subsequent to the initial report, additional information was provided reporting that the 30 day ct follow-up confirmed the type ia endoleak had resolved.No intervention was required.The patient is doing well.

Manufacturer Narrative

Based on the description of the event and provided medical records, clinical assessment confirmed the reported event of the type ia endoleak.Device, user, procedure or anatomy relatedness of this complaint could not be determined due to a lack of relevant imaging.Procedure related harms for this complaint included a femoral endartectomy with patch angioplasty during the procedure.The final patient status was discharged on the ninth post-operative day against medical advice with an active urinary tract infection, unable to determine if this was procedure related or if the patient was admitted with it.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8456553
• MDR Text Key: 140013511
• Report Number: 3008011247-2019-00044
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210907FS083118149
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS083118-14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS092518-32).; OVATION IX ILIAC LIMB (LN FS101918-50).; PALMAZ (NON-ENDOLOGIX).; OVATION IX ILIAC LIMB (LN FS092518-32); OVATION IX ILIAC LIMB (LN FS101918-50); PALMAZ (NON-ENDOLOGIX)
• Patient Outcome(s): Other
• Patient Age: 73 YR