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

Model Number	TV-IL1410120-J
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.The endoleak has been reported under mfr# 2031527-2018-00736.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.During the secondary procedure for treatment of an endoleak, there was an issue with the re-line and the left iliac limb was trapped by a strut and the inner core and nosecone would not come out through the 17fr sheath.The physician pulled extremely hard and the nosecone detached from the system.After some manipulating the physician was able to get the system out.The separated nosecone was retrieved from the patient body.Additionally, due to the physical resistance upon removal of the ovation ix iliac limb system, the left iliac was perforated.The perforation was treated with placement of a non-endologix covered stent.An ovation ix iliac limb was successfully deployed.The patient was stable.No additional event or patient information is available.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported difficulty withdrawing the system and the left iliac perforation was confirmed; the component separation and removal of the foreign body was confirmed by the absence that device on the final angiogram.Additionally, there was evidence to reasonable suggest main body stent cage kinking that was not included in the event as reported.Device, user, procedure or anatomy relatedness could not be determined; the reported extreme torque used by the physician could not be verified; however, likely contributed to the events.Procedure related events and the final patient disposition could not be determined.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.During the secondary procedure for treatment of an endoleak, there was an issue with the re-line and the left iliac limb was trapped by a strut and the inner core and nosecone would not come out through the 17fr sheath.The physician pulled extremely hard and the nosecone detached from the system.After some manipulating the physician was able to get the system out.The separated nosecone was retrieved from the patient body.Additionally, due to the physical resistance upon removal of the ovation ix iliac limb system, the left iliac was perforated.The perforation was treated with placement of a non-endologix covered stent.An ovation ix iliac limb was successfully deployed.The patient was stable.No additional event or patient information is available.Subsequent to the initial report, clinical assessment determined the there was evidence to reasonable suggest main body stent cage kinking that was not included in the event as reported.

• 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: 7959780
• Report Number: 3008011247-2018-00218
• Device Sequence Number: 1571868
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410120J1
• UDI-Public: +M701TVIL1410120J1/$$3210524FS05221849L
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: TV-IL1410120-J
• Device Catalogue Number: TV-IL1410120-J
• Device Lot Number: FS052218-49
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 07/02/2020
• 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: INTUITRAK BIF STENT SYSTEM (LN W11-2017-007).; INTUITRAK INFRA. AORTIC EXT. (LN W11-1359-014).; INTUITRAK BIF STENT SYSTEM (LN W11-2017-007); INTUITRAK INFRA. AORTIC EXT. (LN W11-1359-014)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR