MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1418160-J
Medical Device Problem Codes	Complete Blockage (1094); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Thrombosis (2100); Thrombus (2101)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately 1 year post procedure, the patient presented to the emergency room with a cold leg.Physician elected to administer a lytic and perform an angio-jet.Physician noticed the left iliac limb was higher than the right and physician thought it was impeding flow into that limb.Physician elected to extend the limb to match the other side and put a second stent to trap any additional thrombus left.Final angio looked great and patient was discharged.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows a thrombosed left iliac limb.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a left limb occlusion occurred that was not included in the event as reported.This finding was discovered during an examination of 12-month post implant ct (computed tomography) scan.The most likely causation for the reported event is user-related due to the offset limbs (by 11.5mm) noted at 1-month post implant ct.Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was reported to be doing well and discharged.No additional investigation of this reported adverse event is planned however, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events.Corrections: h6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately 1 year post procedure, the patient presented to the emergency room with a cold leg.Physician elected to administer a lytic and perform an angio-jet.Physician noticed the left iliac limb was higher than the right and physician thought it was impeding flow into that limb.Physician elected to extend the limb to match the other side and put a second stent to trap any additional thrombus left.Final angio looked great and patient was discharged.Additional information: during clinical assessment, occlusion of the left limb was also identified that was not included in the event as reported.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10423685
• Report Number: 3008011247-2020-00091
• Device Sequence Number: 14183983
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418160J1
• UDI-Public: +M701TVIL1418160J1/$$3211031FS10251839P
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 10/31/2021
• Device Model Number: TV-IL1418160-J
• Device Catalogue Number: TV-IL1418160-J
• Device Lot Number: FS102518-39
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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 - FS051518-61; OVATION IX MAIN BODY - FS100518-02; OVATION PRIME FILL POLYMER - FF110218-02; OVATION IX ILIAC LIMB - FS051518-61; OVATION IX MAIN BODY - FS100518-02; OVATION PRIME FILL POLYMER - FF110218-02
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR