MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; ILIAC LIMB

Model Number	TV-IL1412140-J
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.During the initial procedure, there was a polymer leak reported.On (b)(6) 2018 we were informed that the patient had an occluded limb and an angion was going to be performed.Patient received a secondary on (b)(6) 2018 to add an extender to the right limb to cover dissection plane.Flow was re established, but fresh clot formed upon cut down.Patient was receiving tpa drip in the sfa overnight.As of this report, no additional patient sequelae has been reported.
Additional Manufacturer Narrative
Based on the clinical assessment performed the right occlusion, and access site occlusion/dissection (treated medically) are not confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms included the acute occlusion/dissection at the repair of the right sided occlusion (reported endovascular and medical repair).The final patient status was not reported.A definitive root cause was not determined; however, right iliac occlusion - extrinsic stent buckling right iliac stent (7 mm luminal diameter) not treated/recognized at one month post implant and/or present on implant and left external iliac (hypogastric occlusion - ovation stent) off label iliacs are indeterminate contributing factors.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7658746
• Report Number: 3008011247-2018-00155
• Device Sequence Number: 1108520
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412140J1
• UDI-Public: +M701TVIL1412140J1/$$3201017FS09301734I
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: TV-IL1412140-J
• Device Catalogue Number: TV-IL1412140-J
• Device Lot Number: FS093017-34
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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 EXTENDER-LOT: FS081216-30; OVATION LIMB- LOT: FS042516-53; OVATION MAIN BODY-LOT: FS032817-19; OVATION EXTENDER-LOT: FS081216-30; OVATION LIMB- LOT: FS042516-53; OVATION MAIN BODY-LOT: FS032817-19
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR