MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number TV-IL1416100-J

Device Problems Collapse (1099); Kinked (1339); Leak/Splash (1354); Occlusion Within Device (1423)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Occlusion (1984); Pain (1994); Stenosis (2263); Claudication (2550)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be 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 iliac limb stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately 3 weeks post index procedure, the patient presented with claudication and a cold left foot.A ct was done which showed one limb blocking the flow of the other limb leading to an occlusion.A re-intervention was performed where the physician attempted to balloon the occluded limb, however the patient could not tolerate the procedure and expired.

Manufacturer Narrative

Based on the clinical assessment for this event, the most likely cause of the proximal loss of seal was found to be anatomy related, due to the hostile neck anatomy, which likely contributed to the occlusion of the aortic body, right iliac limb stent, and the native vessels down to the popliteal artery.The most likely cause of the occlusion within the stent was found to be the near complete buckling of the right iliac stent at the level of the bifurcation, however, the exact cause of the stent buckling could not be determined.The cause of the death or date of death could not be ascertained due to the lack of medical records surrounding the event.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: OVATION IX
• Type of Device: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 7199542
• MDR Text Key: 97520375
• Report Number: 3008011247-2018-00008
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416100J1
• UDI-Public: +M701TVIL1416100J1/$$3200925FS09061740P
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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: 09/25/2020
• Device Model Number: TV-IL1416100-J
• Device Catalogue Number: TV-IL1416100-J
• Device Lot Number: FS090617-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR