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

Model Number TV-AB3480-I

Device Problem Material Invagination (1336)

Patient Problem Failure of Implant (1924)

Event Date 02/21/2019

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

An ovation ix abdominal stent graft system and one additional ovation ix iliac limb extension were implanted to treat an abdominal aortic aneurysm.At the six (6) month follow-up, ct identified a type ia endloleak due to in-folding at polymer ring.In addition, there is an type ii endoleak from lumbar and a left polar artery.The patient is being monitored.

Manufacturer Narrative

Based on description of the event and medical information available, clinical assessment confirmed the reported events of type ii endoleak from the left polar artery (kidney) and lumbar arteries, type 1a endoleak due to infolding at polymer ring.The compliant is most likely user related due to the off-label neck anatomy at 31mm diameter (ifu stated neck p2+13 to be between 16mm and 30mmin diameter).The procedure related harms for this complaint could not be determined.The final patient status was reported being stable.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.Results codes - 3233 removed, correction.Conclusion codes - 11 removed, correction.

• 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: 8458614
• MDR Text Key: 140117321
• Report Number: 3008011247-2019-00040
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480I1
• UDI-Public: +M701TVAB3480I1/$$3210716FS071018412
• 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
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: TV-AB3480-I
• Device Lot Number: FS071018-41
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS032018-59); OVATION IX ILIAC LIMB (LN FS032218-30); OVATION IX ILIAC LIMB (LN FS040318-68)
• Patient Outcome(s): Other