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

Model Number	TV-IL1414160-J
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	07/01/2018
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 treated with the ovation ix abdominal aortic aneurysm stent.Approximately nine (9) months post initial procedure in (b)(6) 2018, a limb occlusion was detected.The physician plans to reline with an ovation device and will continue to monitor the patient.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; requests were made and an inadequate response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: patient code - remove 1924.Conclusion code - remove 11.
Event or Problem Description
Additional information received confirming that the re-intervention planned for on (b)(6) 2018 was cancelled.Multiple attempts have been made to confirm if a secondary procedure was rescheduled or completed for the patient, but no response was received.This complaint will be updated if additional information is received at a later time.

• 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: 8178626
• Report Number: 3008011247-2018-00259
• Device Sequence Number: 11095916
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414160J1
• UDI-Public: +M701TVIL1414160J1/$$3200613FS04281724O
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 06/13/2020
• Device Model Number: TV-IL1414160-J
• Device Catalogue Number: TV-IL1414160-J
• Device Lot Number: FS042817-24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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:FS082517-59; OVATION IX-MAIN BODY:FS050517-14; OVATION IX-ILIAC LIMB: (B)(4); OVATION IX-MAIN BODY: (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR