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

Model Number	TV-IL1422160-J
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/30/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.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 (aaa).During the investigation of a previously reported event, 3008011247-2019-00058, right limb stenosis was discovered per discharge summary from (b)(6) 2015 due to mechanical compression from the left iliac stent.A resultant bilateral secondary endovascular procedure occurred on (b)(6) 2015 with a bifurcated iliac branch device, right femoral endartectomy, and bovine pericardial patch angioplasty.The patient tolerated the procedure well and was discharged one-day postoperative.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported right iliac limb stenosis due to mechanical compression was confirmed and is most likely user related (crossing of limb stents proximally).No procedure related harms were identified.The final patient status was discharge home on the first post-operative day stable following a secondary endovascular procedure.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.

• 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: 8759813
• Report Number: 3008011247-2019-00104
• Device Sequence Number: 16564089
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422160J1
• UDI-Public: +M701TVIL1422160J1/$$3160908FS06261505W
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 09/08/2016
• Device Model Number: TV-IL1422160-J
• Device Catalogue Number: TV-IL1422160-J
• Device Lot Number: FS062615-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/09/2020
• 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 (LN FS062615-06).; OVATION IX MAIN BODY (LN FS081015-14).; OVATION IX ILIAC LIMB (LN FS062615-06); OVATION IX MAIN BODY (LN FS081015-14)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR