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

Model Number TV-AB2380-J

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problems Failure of Implant (1924); Ischemia (1942); Neurological Deficit/Dysfunction (1982); Occlusion (1984); Thrombosis (2100)

Event Date 10/16/2017

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 abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately one hour after the index procedure, the patient reportedly had a cold left leg.The patient returned to the operating room where it was determined that there was a clot in the aortic body stent graft.Two atrium icast grafts were "kissed" together in the aortic body stent graft which successfully restored flow.As of the date of this report, there have been no additional patient sequelae reported.

Manufacturer Narrative

Based on the clinical assessment for this event, the most likely cause of the left iliac limb occlusion was determined to be user related, due to the reported 'hourglass' appearance of the trunk of the main body.Index procedure angiography demonstrated what was likely a twist in the trunk of the aortic body and proximal unsupported legs due to the positioning of the iliac limbs, causing the flow lumen to narrow.The final patient disposition was discharged on post-operative day nineteen.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.Codes: (b)(4).

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• 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: 7034430
• MDR Text Key: 92100967
• Report Number: 3008011247-2017-00088
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Public: +M701TVAB2380J1/$$3200524FS04071731+
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

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: 05/31/2020
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS040717-31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2017
• 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): Required Intervention
• Patient Age: 66 YR