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

Model Number	TV-IL1412120-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Approximately 18 (eighteen) months later, left limb thrombosis was detected.Successful re-intervention was performed with open thrombectomy of the limb with patch angioplasty of the right common femoral artery.In addition bilateral 9x38 non-endologix ptfe covered balloon expandable stents were implanted to extended the limbs proximally.
Additional Manufacturer Narrative
Based on description of the event and medical information available, clinical assessment confirmed the reported event of the left limb occlusion, secondary endovascular procedure and open thrombectomy of the left limb.Device, user, procedure or anatomy relatedness of this event could not be determined due to lack of diagnostic imaging.Additionally, procedure related harms for this event could not be determined.The final patient status was not reported.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
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8341739
• Report Number: 3008011247-2019-00019
• Device Sequence Number: 16591528
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412120J1
• UDI-Public: +M701TVIL1412120J1/$$3190606FS03111661J
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2019
• Device Model Number: TV-IL1412120-J
• Device Catalogue Number: TV-IL1412120-J
• Device Lot Number: FS031116-61
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB (LN FS021617-04); OVATION IX MAIN BODY (LN FS031617-26)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR