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

Model Number	TV-IL1428120-J
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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
A re-intervention was preformed.The physician elected to coil the left common iliac artery and extended the limb with two (2) ovation limb stents.The endoleak was resolved and the patient did well.
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 4.5 years post initial procedure, a type 1b endoleak was identified.A re-intervention was preformed.The physician elected to coil the left common iliac artery and extended the limb with two (2) ovation limb stents.The endoleak was resolved and the patient did well.Additional information: there was evidence to suggest left iliac stent cranial migration of 29mm occurred.The stent migration was discovered during review of the 54 month post implant ct (computed tomography) scan.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, the type 1b endoleak of the left common iliac artery event was confirmed.Additionally, a left iliac stent cranial migration of 29mm also occurred.These events are most likely anatomy related due to significant infrarenal angulation of 50 degrees.The final patient status was reported to be well following a successful endovascular procedure.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 SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10099053
• Report Number: 3008011247-2020-00066
• Device Sequence Number: 11598733
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428120J1
• UDI-Public: +M701TVIL1428120J1/$$3160630FS03171508Q
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 06/30/2016
• Device Model Number: TV-IL1428120-J
• Device Catalogue Number: TV-IL1428120-J
• Device Lot Number: FS031715-08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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: ILIAC LIMB, LOT FS031715-06; MAIN BODY, LOT FS072215-49; POLYMER, LOT FF010715-04
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR