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

Model Number	TV-IL1412140-J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/21/2018
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
Endologix became aware of a left limb pulling up into the abdominal aortic aneurysm sac on (b)(6) 2018 as reported by physician (b)(6) at (b)(6) medical center.The date of event is also (b)(6) 2018 based on routine follow-up cta scan which diagnosed the reported movement of the distal attachment seal in the left common iliac.The patient was originally implanted with an ovation ix main body and three (3) ovation ix iliac limbs on (b)(6) 2017 by the reporting physician.During re-intervention, the patient was treated by implanting an additional ovation ix iliac limb on (b)(6) 2018 by physician (b)(6), who determined that the left common iliac was too diseased to land, tray and seal in.The left internal was diseased and stenotic at its origin as well.The patient is doing well.
Event or Problem Description
Additional information received confirming per routine follow-up cta completed on (b)(6) 2018, post secondary repair, the left iliac has no endoleak and the aneurysm sac is stable is size with no change.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported event: left common iliac artery stent movement.The complaint is most likely user related; case was undersized on the contra side.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be doing well post the secondary endovascular procedure.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7609372
• Report Number: 3008011247-2018-00138
• Device Sequence Number: 1512336
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412140J1
• UDI-Public: +M701TVIL1412140J1
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 05/21/2018

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: Physician
• Device Expiration Date: 04/25/2019
• Device Model Number: TV-IL1412140-J
• Device Catalogue Number: TV-IL1412140-J
• Device Lot Number: FS091815-49
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 05/21/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/14/2018; 10/10/2018
• 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 IX-ILIAC LIMB - LOT FS032316-17; OVATION IX-ILIAC LIMB - LOT FS110415-21; OVATION IX-MAIN BODY - LOT FS042017-37; OVATION IX-ILIAC LIMB - LOT FS032316-17; OVATION IX-ILIAC LIMB - LOT FS110415-21; OVATION IX-MAIN BODY - LOT FS042017-37
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR